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Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain

Sponsor
Mitosynergy LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04737278
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Male and female participants were selected based on chronic neuromuscular pain. Patients were instructed to take two doses of the placebo or cuprous nicotinic acid chelate Cunermusmir twice a day for 28 days. Hypothesis: Cunermuspir would improve quality of life as determined by several questionnaires.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

A total of 72 subjects were consented and screened, with 56 subjects (28 males and 28 female) being eligible to participate in the study. Fifty-six subjects with muscle/nerve pain were randomized at a ratio of 1:1 to one of two treatment groups. To evaluate primary and secondary objectives, study assessments were conducted at Baseline, and Day 28 ± 2. The Individualized Neuromuscular Quality of Life Questionnaire (INQoL), Symptom Impact Questionnaire (SQIR), Mini-Mental State Examination (MMSE) were completed by participants to assess physical function, pain, fatigue/energy and cognitive function.

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, double--blind, placebo controlled, parallel studyrandomized, double--blind, placebo controlled, parallel study
Masking:
Double (Participant, Investigator)
Masking Description:
The investigational product bottles were labeled according to the requirements of ICH--GCP guidelines and applicable local regulatory guidelines. Investigational products were coded by the unblinded personnel at KGK Synergize who were not involved in the collecting or analyzing of study data. Each package contained a similar label differing only in randomization number.
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating the Safety and Efficacy of Cunermuspir on Energy, Strength, Fatigue and Discomfort in Subjects With Nerve or Muscle Pain
Actual Study Start Date :
Jan 28, 2014
Actual Primary Completion Date :
May 28, 2014
Actual Study Completion Date :
Sep 29, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cunermuspir

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Drug: Cunermuspir
Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide
Other Names:
  • cuprous nicotinic acid

    		•
    Placebo Comparator: Placebo

    Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

    Other: Placebo
    same non-medical ingredients and encapsulation as Intervention 1

    Outcome Measures

    Primary Outcome Measures

    1. Neuromuscular Symptoms [baseline and 28 days after enrollment]

      Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact.

    2. Platelet ATP [baseline and 28 days after enrollment]

      Platelet ATP levels were measured as previously published in the literature.

    Secondary Outcome Measures

    1. Household Chores and Neuro Muscular Sumptoms [baseline and 28 days after enrollment]

      Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between "no difficulty" and "extremely difficult" No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact.

    2. Cognition [baseline and 28 days after enrollment]

      Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to "cognition." Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure.

    3. Heart Rate [baseline and 28 days after enrollment]

      heart rate is measured in beats per minute

    4. Diastolic Blood Pressure [baseline and 28 days after enrollment]

      The diastolic blood pressure was measured in mm Hg

    5. Systolic Blood Pressure [baseline and 28 days after enrollment.]

      Systolic blood pressure was measured in mm Hg

    6. Hemoglobin [baseline and 28 days after enrollment.]

      changes measured in g/L blood

    7. Hematocrit [baseline and 28 days after enrollment]

      changes in the fraction of whole blood occupied by red blood cells measured as L/L

    8. WBC [baseline and 28 days after enrollment]

      changes in white blood cells (WBC) measured in units of 10^9 per liter blood

    9. RBC [baseline and 28 days after enrollment]

      changes in red blood cells (RBC) measured in units of 10^12 per liter blood

    10. MCV [baseline and 28 days after enrollment]

      changes in mean corpuscular volume (MCV) measured in units of fL

    11. MCH [baseline and 28 days after enrollment]

      changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC

    12. MCHC [baseline and 28 days after enrollment]

      mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L

    13. RDW [baseline and 28 days after enrollment]

      changes in the RBC distribution width (RDW) are reported in units of percentage (%)

    14. Platelets [baseline and 28 days after enrollment]

      changes in the platelet counts are reported in units of 10^9 per liter blood

    15. Neutrophils [baseline and 28 days after enrollment]

      changes in neutrophils are reported in units of 10^9 per liter blood

    16. Lymphocyte [baseline and 28 days after enrollment]

      changes in lymphocytes are reported in units of 10^9 per liter blood

    17. Monocyte [baseline and 28 days after enrollment]

      changes in monocytes are reported in units of 10^9 per liter blood

    18. Eosinophil [baseline and 28 days after enrollment]

      changes in eosinophils are reported in units of 10^9 cells per liter blood

    19. Basophil [baseline and 28 days after enrollment]

      changes in basophils are reported in units of 10^9 cells per liter blood

    20. NLR [baseline and 28 days after enrollment]

      Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1

    21. Glucose [baseline and 28 days after enrollment]

      changes in blood glucose are reported in units of mmol per liter

    22. Urea [baseline and 28 days after enrollment]

      changes in renal function as measured by blood urea are reported in units of mmol per liter

    23. Creatinine [baseline and 28 days after enrollment]

      changes in creatinine are reported in units of micromol per liter

    24. eGFR [baseline and 28 days after enrollment]

      changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2

    25. Sodium [baseline and 28 days after enrollment]

      changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com

    26. Potassium [baseline and 28 days after enrollment]

      changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com

    27. Chloride [baseline and 28 days after enrollment]

      changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com

    28. Bilirubin [baseline and 28 days after enrollment]

      changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37

    29. ALT [baseline and 28 days after enrollment]

      changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com

    30. AST [baseline and 28 days after enrollment]

      changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com

    31. GGT [baseline and 28 days after enrollment]

      changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter

    32. Copper [baseline and 28 days after enrollment]

      changes in copper concentration in the blood are reported in units of micro moles per liter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female age 18-75

    • If female, subject is not of child bearing potential. Defined as females who have

    • had a hysterectomy or oophorectomy.

    • bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).

    • Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo--Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Vasectomy of partner, Total Abstinence

    • Subject has unresolved persistent muscle or nerve pain (muscle or nerve pain population)

    • Subjects using other therapies for nerve/muscle pain (e.g., exercise, TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc), must be used at a stable schedule for 1 month prior to the trial and subject agrees to continue these therapies at the same schedule during the trial avoiding changes in frequency or intensity and to record therapies in the study diary

    • Agrees to comply with study procedures

    • Has given voluntary, written, informed consent to participate in

    • the study

    Exclusion Criteria:

    • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial

    • Planned surgery during the course of the trial

    • Use of prescription drugs for fibromyalgia or nerve pain (e.g.Lyrica, Cymbalta and Savella and others).

    • Use of prescription medications for depression, anxiety or other mental disorders

    • Requires the use of prescription drugs to control pain (other than provided rescue medication)

    • Use of oral or topical prescription or over the counter medications or natural health products for pain relief 3 days prior to randomization and during the trial (other than provided rescue medication)

    • Use of natural health products including vitamins and minerals within 3 days prior to randomization and during the trial

    • Use of blood thinning medications (e.g. warfarin)

    • Chronic lyme disease or chronic parasitic infections

    • Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg

    • Subjects with diabetes

    • History of bleeding disorders, or significant blood loss in the past 3 months

    • Alcohol use >2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year

    • Allergy or sensitivity to study supplement ingredients or acetaminophen

    • Participation in a clinical research trial within 30 days prior to randomization

    • Individuals who are cognitively impaired and/or who are unable to give informed consent

    • Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KGK Synergize now KGK Science London Ontario Canada N6A 5R8

    Sponsors and Collaborators

    • Mitosynergy LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitosynergy LLC
    ClinicalTrials.gov Identifier:
    NCT04737278
    Other Study ID Numbers:
    • 13MFHM
    First Posted:
    Feb 3, 2021
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mitosynergy LLC
    Copper
    nicotinic acid
    energy
    strength
    fatigue
    nerve pain
    muscle pain
    neuralgia
    myalgia
    Additional relevant MeSH terms:
    Myalgia
    Neuralgia
    Fatigue
    Nicotinic Acids
    Niacin

    Study Results

    Participant Flow

    Recruitment Details A total of 56 met the enrollment requirements. Of these only 49 completed the study
    Pre-assignment Detail
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Period Title: Overall Study
    STARTED 28 28
    COMPLETED 24 25
    NOT COMPLETED 4 3

    Baseline Characteristics

    Arm/Group Title Cunermuspir Placebo Total
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1 Total of all reporting groups
    Overall Participants 28 28 56
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    27
    96.4%
    28
    100%
    55
    98.2%
    >=65 years
    1
    3.6%
    0
    0%
    1
    1.8%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    45.4
    (13.6)
    48.2
    (10.4)
    46.8
    (12.1)
    Sex: Female, Male (Count of Participants)
    Female
    13
    46.4%
    15
    53.6%
    28
    50%
    Male
    15
    53.6%
    13
    46.4%
    28
    50%
    Region of Enrollment (participants) [Number]
    Canada
    28
    100%
    28
    100%
    56
    100%

    Outcome Measures

    1. Primary Outcome
    Title Neuromuscular Symptoms
    Description Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact.
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 24 25
    baseline
    36.5
    (16.4)
    43.5
    (21.1)
    Day 28
    28.5
    (18.6)
    32.7
    (23.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Other
    Comments test of the hypothesis that the score on day 28 is different from the baseline score in the Placebo group
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments test of the hypothesis that the score on day 28 is different than the baseline score
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method t-test, 2 sided
    Comments
    2. Primary Outcome
    Title Platelet ATP
    Description Platelet ATP levels were measured as previously published in the literature.
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    ATP isolated from platelets. Some samples were not used for analysis due to contamination with red blood cells.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 21 25
    baseline
    43.6
    (16.4)
    42
    (13.1)
    day 28
    59.2
    (20.1)
    51.2
    (15.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p<0.05. Within group comparisons were made using the paired Student's t test.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.15
    Comments
    Method t-test, 2 sided
    Comments
    3. Secondary Outcome
    Title Household Chores and Neuro Muscular Sumptoms
    Description Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between "no difficulty" and "extremely difficult" No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact.
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 24 25
    baseline
    27.6
    (16.8)
    34.9
    (16.9)
    day 28
    16.7
    (10.9)
    29.3
    (28.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments comparison made between placebo and Cunermuspir at baseline
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments comparison made at day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments comparison between baseline and day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments
    Method t-test, 2 sided
    Comments
    4. Secondary Outcome
    Title Cognition
    Description Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to "cognition." Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure.
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 24 25
    baseline
    18
    64.3%
    16
    57.1%
    day 28
    22
    78.6%
    18
    64.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments base line between group comparisons
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.54
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.14
    Comments
    Method Fisher Exact
    Comments
    5. Secondary Outcome
    Title Heart Rate
    Description heart rate is measured in beats per minute
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    70.3
    (10.8)
    68.2
    (8.1)
    day 28
    68.3
    (9.7)
    69.7
    (9.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.54
    Comments
    Method ANCOVA
    Comments
    6. Secondary Outcome
    Title Diastolic Blood Pressure
    Description The diastolic blood pressure was measured in mm Hg
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    70.5
    (6.4)
    75.0
    (9.4)
    day 28
    69.3
    (7.3)
    74.6
    (7.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANCOVA
    Comments
    7. Secondary Outcome
    Title Systolic Blood Pressure
    Description Systolic blood pressure was measured in mm Hg
    Time Frame baseline and 28 days after enrollment.

    Outcome Measure Data

    Analysis Population Description
    For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    111.7
    (10.6)
    114.6
    (13.1)
    day 28
    109.5
    (15.8)
    112.3
    (11.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.31
    Comments
    Method ANCOVA
    Comments
    8. Secondary Outcome
    Title Hemoglobin
    Description changes measured in g/L blood
    Time Frame baseline and 28 days after enrollment.

    Outcome Measure Data

    Analysis Population Description
    For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    140.3
    (12.9)
    141.3
    (12.4)
    day 28
    142.2
    (14.3)
    141.0
    (12.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments
    Method ANCOVA
    Comments
    9. Secondary Outcome
    Title Hematocrit
    Description changes in the fraction of whole blood occupied by red blood cells measured as L/L
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    0.411
    (0.034)
    0.416
    (0.032)
    day 28
    0.416
    (0.038)
    0.415
    (0.031)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.84
    Comments
    Method ANCOVA
    Comments
    10. Secondary Outcome
    Title WBC
    Description changes in white blood cells (WBC) measured in units of 10^9 per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    5.93
    (1.57)
    5.82
    (1.50)
    day 28
    5.88
    (1.81)
    6.00
    (1.34)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.63
    Comments
    Method ANCOVA
    Comments
    11. Secondary Outcome
    Title RBC
    Description changes in red blood cells (RBC) measured in units of 10^12 per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    4.76
    (0.38)
    4.74
    (0.38)
    day 28
    4.82
    (0.41)
    4.73
    (0.38)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method ANCOVA
    Comments
    12. Secondary Outcome
    Title MCV
    Description changes in mean corpuscular volume (MCV) measured in units of fL
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    86.2
    (3.9)
    87.7
    (3.1)
    day 28
    86.4
    (4.3)
    87.7
    (3.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANCOVA
    Comments
    13. Secondary Outcome
    Title MCH
    Description changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    29.5
    (1.64)
    29.81
    (1.36)
    day 28
    29.48
    (1.69)
    29.86
    (1.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANCOVA
    Comments
    14. Secondary Outcome
    Title MCHC
    Description mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    342.4
    (8.2)
    339.9
    (7.8)
    day 28
    341.2
    (6.4)
    340.5
    (5.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments
    Method ANCOVA
    Comments
    15. Secondary Outcome
    Title RDW
    Description changes in the RBC distribution width (RDW) are reported in units of percentage (%)
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    13.78
    (0.70)
    13.80
    (0.50)
    day 28
    13.77
    (0.63)
    13.93
    (0.58)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments
    Method ANCOVA
    Comments
    16. Secondary Outcome
    Title Platelets
    Description changes in the platelet counts are reported in units of 10^9 per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    By day 28 three participants were lost to followup: two in the Cunermuspir group and one in the placebo group. There were issues in handling of one platelet sample in the Cunermuspir group. This brings the number in the Cunermuspir group down to 25 on day 28. For technical reasons, platelet data are missing for subject 021. All other blood cell data are present in this report of data.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    250
    (62)
    266
    (71)
    day 28
    255
    (65)
    269
    (69)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method ANCOVA
    Comments
    17. Secondary Outcome
    Title Neutrophils
    Description changes in neutrophils are reported in units of 10^9 per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    3.28
    (1.06)
    3.35
    (1.13)
    day 28
    3.15
    (1.19)
    3.60
    (1.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments comparison of neutrophils from baseline to day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method t-test, 2 sided
    Comments
    18. Secondary Outcome
    Title Lymphocyte
    Description changes in lymphocytes are reported in units of 10^9 per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    2.01
    (0.64)
    1.83
    (0.51)
    day 28
    2.04
    (0.72)
    1.74
    (0.51)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANCOVA
    Comments
    19. Secondary Outcome
    Title Monocyte
    Description changes in monocytes are reported in units of 10^9 per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    0.450
    (0.137)
    0.475
    (0.140)
    day 28
    0.473
    (0.176)
    0.500
    (0.124)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments comparison of baseline values
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.47
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments comparison performed on data from day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.24
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    20. Secondary Outcome
    Title Eosinophil
    Description changes in eosinophils are reported in units of 10^9 cells per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    0.154
    (0.074)
    0.143
    (0.063)
    day 28
    0.181
    (0.110)
    0.130
    (0.072)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments comparison of eosinophil counts at day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    21. Secondary Outcome
    Title Basophil
    Description changes in basophils are reported in units of 10^9 cells per liter blood
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    0.0107
    (0.0315)
    0.0071
    (0.0262)
    day 28
    0.0077
    (0.0272)
    0.0074
    (0.0267)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments The day 28 basophil counts on day 28 were compared between the two arms of this study.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.98
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    22. Secondary Outcome
    Title NLR
    Description Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    1.77
    (0.15)
    1.90
    (0.13)
    day 28
    1.67
    (0.14)
    2.24
    (0.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site: http://vassarstats.net/anova2u.html
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.025
    Comments This p value is for the treatment source. Visits (p=0.422) and visits x treatments (p=0.153) did not meet the threshold of significance.
    Method ANOVA
    Comments
    23. Secondary Outcome
    Title Glucose
    Description changes in blood glucose are reported in units of mmol per liter
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    In this population the initial screening was considered the baseline for all blood chemistry parameters. Three of the the participants were lost to followup or withdrew from the study
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    5.12
    (0.55)
    5.30
    (0.42)
    day 28
    5.25
    (0.44)
    5.24
    (0.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Comparison of enrollment baseline blood glucose and day 28 in the placebo arm
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.04
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.92
    Comments
    Method ANCOVA
    Comments
    24. Secondary Outcome
    Title Urea
    Description changes in renal function as measured by blood urea are reported in units of mmol per liter
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    5.16
    (1.13)
    5.33
    (1.25)
    day 28
    5.05
    (1.57)
    5.26
    (1.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.51
    Comments
    Method ANCOVA
    Comments
    25. Secondary Outcome
    Title Creatinine
    Description changes in creatinine are reported in units of micromol per liter
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    72.2
    (11.6)
    72.9
    (16.0)
    day 28
    72.3
    (13.7)
    73.7
    (15.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments
    Method ANCOVA
    Comments
    26. Secondary Outcome
    Title eGFR
    Description changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    90.4
    (17.3)
    88.8
    (16.2)
    day 28
    91.2
    (18.3)
    85.9
    (15.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method ANCOVA
    Comments
    27. Secondary Outcome
    Title Sodium
    Description changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    143.39
    (2.25)
    143.14
    (2.16)
    day 28
    142.62
    (2.47)
    141.89
    (2.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.23
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Blood sodium concentration between baseline and day 28 in the Placebo group.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method t-test, 2 sided
    Comments
    28. Secondary Outcome
    Title Potassium
    Description changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    The study sponsor is of the opinion that these participants were dehydrated when they started the study. They were instructed to drink more water. Three of the 56 that started the study were lost to followup or withdrew.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    4.86
    (0.45)
    4.84
    (0.45)
    day 28
    4.44
    (0.43)
    4.39
    (0.39)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.58
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participants
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    29. Secondary Outcome
    Title Chloride
    Description changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Enrollment pre-screening values are taken as the baseline. The study sponsor was of the opinion that these participants started the study dehydrated. Of the original 56 three were lost to followup or withdrew.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    106.14
    (2.12)
    106.43
    (2.27)
    day 28
    105.08
    (2.23)
    105.15
    (1.99)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.87
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments comparison between baseline and day 28 chloride concentrations in the Cunermuspir group
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method t-test, 2 sided
    Comments
    30. Secondary Outcome
    Title Bilirubin
    Description changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    11.0
    (5.9)
    9.3
    (3.5)
    day 28
    11.2
    (5.9)
    9.9
    (4.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments Bilirubin concentrations between Placebo and Cunermuspir compared at day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.36
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Arm
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.72
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments Wilcoxon Signed-Rank
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.35
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    31. Secondary Outcome
    Title ALT
    Description changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    27.6
    (12.8)
    28.5
    (16.3)
    day 28
    28.2
    (15.5)
    28.4
    (15.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.95
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments comparison between baseline and day 28 values in Cunermuspir group
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments comparison between baseline and day 28 values for the Placebo Arm
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    32. Secondary Outcome
    Title AST
    Description changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    23.0
    (4.9)
    23.1
    (6.3)
    day 28
    24.2
    (6.2)
    25.8
    (9.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebo
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.62
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments baseline to day 28 comparison
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.24
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments baseline to day 28 comparison of AST activity in Placebo group
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    33. Secondary Outcome
    Title GGT
    Description changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    20.9
    (13.6)
    28.6
    (36.6)
    day 28
    24.0
    (18.1)
    25.6
    (23.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments comparison between placebo and Cunermuspir at day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments Comparison of GGT activities in blood of two arms: Cunermuspir and Placebo on Day 28
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments Comparison of GGT activities in participants' blood at baseline and on day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Wilcoxon Signed Rank
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.97
    Comments
    Method Wilcoxon Signed-Rank
    Comments
    34. Secondary Outcome
    Title Copper
    Description changes in copper concentration in the blood are reported in units of micro moles per liter
    Time Frame baseline and 28 days after enrollment

    Outcome Measure Data

    Analysis Population Description
    Of the 56 enrolled in the study three were lost to followup or dropped out.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    Measure Participants 28 28
    baseline
    16.18
    (2.42)
    17.62
    (2.51)
    day 28
    16.6
    (2.8)
    17.57
    (2.89)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
    Comments Between group comparisons were made using ANCOVA
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cunermuspir
    Comments comparison of baseline with day 28
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments comparison between baseline and day 28 serum copper concentrations in the Placebo Arm
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.89
    Comments
    Method t-test, 2 sided
    Comments

    Adverse Events

    Time Frame 28 days
    Adverse Event Reporting Description All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.
    Arm/Group Title Cunermuspir Placebo
    Arm/Group Description Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
    All Cause Mortality
    Cunermuspir Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/28 (0%) 0/28 (0%)
    Serious Adverse Events
    Cunermuspir Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/28 (0%) 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    Cunermuspir Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/26 (23.1%) 7/27 (25.9%)
    Gastrointestinal disorders
    nasea 4/26 (15.4%) 4 3/27 (11.1%) 3
    Infections and infestations
    seasonal respiratory infections 2/26 (7.7%) 2 4/27 (14.8%) 5
    Nervous system disorders
    head ache 2/26 (7.7%) 2 1/27 (3.7%) 1
    Skin and subcutaneous tissue disorders
    moderate dermatitis 1/26 (3.8%) 1 0/27 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The study PI (Dale Wilson) retired soon after the study was completed. KGK Synergize has undergone reorganization as KGK Science. The original intent was to publish the study results in a peer review journal.

    Results Point of Contact

    Name/Title Dr Barbara Leinweber, PhD
    Organization BDL Biochemistry, consultant for Mitosynergy
    Phone (520)334-5444
    Email barb@bdlbiochem.com
    Responsible Party:
    Mitosynergy LLC
    ClinicalTrials.gov Identifier:
    NCT04737278
    Other Study ID Numbers:
    • 13MFHM
    First Posted:
    Feb 3, 2021
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Mar 1, 2021