Feasibility and Effectiveness of Micronutrients as Palliative Care Therapy in Patients With Congestive Heart Failure
Study Details
Study Description
Brief Summary
The purpose of this project is to conduct a preliminary test of the feasibility of a multi-micronutrient intervention to improve micronutrient status, cardiac function and quality of life in Veterans with Congestive Heart Failure (CHF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
Veterans with stable CHF resulting from ischemic cardiomyopathy with systolic dysfunction and an ejection fraction ≤45% and who fit the criteria of stage B, C and D 2 heart failure will be recruited. This is a one group study with Veterans serving as their own control. They will receive 50 mg thiamin, vitamin B50 and 220 mg Zn as Zn sulfate daily for 6 months. Additionally, they will receive 50,000 IU Vitamin D as ergocalciferol each week for 8 weeks then every other week for 16 weeks. Pre (baseline) and post (6 months) cardiac function will be tested with echocardiogram and cardiac MR (when applicable), biochemical measures of thiamine, pyridoxine, zinc and Vitamin D will be measured at baseline, 3 months, 6 months and one year. Quality of life will be measured using the Minnesota Living with Heart Failure questionnaire baseline, month 3,6,and one year. Nutritional assessment including a nutrition focused physical examination and three days food records will also be measured at baseline, month 3, 6 and one year.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Micronutrients Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
Drug: Micronutrients
Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Left Ventricular Ejection Fraction by Echocardiogram [Change from baseline in Left Ventricular Ejection Fraction at 6 months]
Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram. The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening.
- Change in Left Ventricular Ejection Fraction as Measured by Magnetic Resonance Imaging (MRI) [Change from baseline in Left Ventricular Ejection Fraction at 6 months]
Left Ventricular Ejection Fraction Measured by Magnetic Resonance Imaging (MRI). The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening.
Secondary Outcome Measures
- Change in Quality of Life [Change from baseline Quality of Life at 3 months]
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 -5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 3 months was calculated by subtracting the 3 month score from the baseline score. A lower score at 3 months indicates better QOL and a high score at 3 months indicates a worse QOL.
- Nutritional Status [Change from baseline in nutritional status at 3 months]
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 3 months.
- Change in Quality of Life [Change from baseline quality of life at 6 months]
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 6 months was calculated by subtracting the 6 month score from the baseline score. A lower score at 6 months indicates better QOL and a higher score at 6 months indicates a worse QOL.
- Change on Quality of Life [Change from baseline quality of life at 12 months]
The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 12 months was calculated by subtracting the 12 month score from the baseline score. A lower score at 12 months indicates better QOL and a higher score at 12 months indicates a worse QOL.
- Nutritional Status [Change from baseline in nutritional status at 6 months]
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 6 months.
- Nutritional Status [Change from baseline in nutritional status at 12 months]
Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 12 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
- stable CHF (three months without an exacerbation or major change in medication regimen and cardiology provider determined medication regimen (angiotensin II receptor blockers (ARBs), aldosterone, angiotensin converting enzyme (ACE) inhibitors and Beta blockers) has been maximized), Stage B, C or D CHF resulting from ischemic cardiomyopathy with an ejection fraction ≤ 45% with or without a pacemaker or defibrillator . Potential participants who require further medication titration to attain maximal benefit, will need to wait 30 days after the provider has maximized the dose of medication to participate.
Exclusion Criteria:
- recent (within the last three months) acute myocardial infarction, or unstable angina, pacemaker or defibrillator placed less than six months prior, or anticipated pacemaker or defibrillator placement in the next six months, or a bi ventricular pacemaker, corticosteroid use (> 20 mg Prednisone use or its equivalent per day > 2 weeks duration), isoniazid therapy, use of the study nutrition supplements at the study doses for the past month or longer,(if the participant has been taking a multivitamin or multivitamin with minerals , or other water soluble vitamins they will need to stop taking these for at least one month prior to initiating the study intervention), end-stage liver disease, end-stage renal disease requiring dialysis, receiving chemotherapy or radiation therapy, active alcohol/ substance abuse, pregnancy /lactation, women of childbearing potential who do not have medical documentation of surgically induced menopause, pancreatitis, any psychological issues like severe depression, claustrophobia, active problematic post-traumatic stress disorder (PTSD), or memory loss that prevents compliance with the supplement intake, agoraphobia which may interfere attendance at research visits or fear of needles which would limit their ability to have the blood tests completed, and any active eating disorders. Cardiac Magnetic Resonance Imaging (MRI) scan will not be used to test cardiac function in participants with a pacemaker or defibrillator. Nor will it be used for potential subjects with ferro magnetic materials (i.e., penile stimulator), inability to lie flat for up to one hour, inability to hold their breath for up to 15 seconds or those with claustrophobia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phoenix VA Health Care System | Phoenix | Arizona | United States | 85012 |
Sponsors and Collaborators
- Phoenix VA Health Care System
Investigators
- Principal Investigator: Diane J Parrington, PhD, Phoenix VA Health Care System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Parrington 005
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 40 participants consented to the study. Twelve were screen failures and six withdrew following consent but prior to their first visit when baseline data collection would have taken place and the intervention would have started. Therefore twenty-two participants received the intervention. The participants served as their own control, so there is only one arm of the study. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Period Title: Overall Study | |
| STARTED | 28 |
| Treated | 22 |
| COMPLETED | 20 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Overall Participants | 22 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
12
54.5%
|
| >=65 years |
10
45.5%
|
| Age (years) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [years] |
64.0
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
22
100%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| African American |
2
9.1%
|
| Caucasian |
19
86.4%
|
| Hispanic |
1
4.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
22
100%
|
| Minnesota Living with Heart Failure Questionnaire (units on a scale) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [units on a scale] |
15.0
|
| Serum vitamin B1 (nmoL/L) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [nmoL/L] |
122
|
| Serum B6 (ng/mL) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [ng/mL] |
7.6
|
| Serum Zinc (mcg/dL) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [mcg/dL] |
76.0
|
| Serum Vitamin D (ng/mL) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [ng/mL] |
32.1
|
Outcome Measures
| Title | Change in Left Ventricular Ejection Fraction by Echocardiogram |
|---|---|
| Description | Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram. The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening. |
| Time Frame | Change from baseline in Left Ventricular Ejection Fraction at 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All individuals in whom either baseline or 6 month measures were obtained. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b |
| Measure Participants | 21 |
| Least Squares Mean (Standard Error) [Percent] |
1.1
(2.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Micronutrients |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Change in Left Ventricular Ejection Fraction as Measured by Magnetic Resonance Imaging (MRI) |
|---|---|
| Description | Left Ventricular Ejection Fraction Measured by Magnetic Resonance Imaging (MRI). The measure is the difference between the LVEF at 6 months from the baseline LVEF. A higher LVEF shows improvement and a lower LVEF shows worsening. |
| Time Frame | Change from baseline in Left Ventricular Ejection Fraction at 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All persons with at least one measurement of LVEF by MRI. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid & pyridoxine, 100 microgram (mcg) folic acid, & 50 mcg cyanocobalamin (B12) & biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Measure Participants | 13 |
| Least Squares Mean (Standard Error) [Percent] |
3.8
(3.4)
|
| Title | Change in Quality of Life |
|---|---|
| Description | The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 -5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 3 months was calculated by subtracting the 3 month score from the baseline score. A lower score at 3 months indicates better QOL and a high score at 3 months indicates a worse QOL. |
| Time Frame | Change from baseline Quality of Life at 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All individuals with either baseline or 3 month measure of Quality of Life. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tabdaily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) Micronutrients: Thiamin one tab daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 |
| Measure Participants | 22 |
| Least Squares Mean (Standard Error) [units on a scale] |
-8.3
(6.9)
|
| Title | Nutritional Status |
|---|---|
| Description | Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 3 months. |
| Time Frame | Change from baseline in nutritional status at 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All with both baseline and 3 month assessment of nutritional status |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg) folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tab daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) Micronutrients: Thiamin one tab daily provides 50 mg of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 IU tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tab daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Measure Participants | 22 |
| Median (Inter-Quartile Range) [score on a scale] |
0
|
| Title | Change in Quality of Life |
|---|---|
| Description | The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 6 months was calculated by subtracting the 6 month score from the baseline score. A lower score at 6 months indicates better QOL and a higher score at 6 months indicates a worse QOL. |
| Time Frame | Change from baseline quality of life at 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All individuals with either a baseline or six month measure of Quality of Life. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid & pyridoxine, 100 microgram (mcg) folic acid, & 50 mcg cyanocobalamin (B12) & biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Measure Participants | 22 |
| Least Squares Mean (Standard Error) [units on a scale] |
-5.9
(7.0)
|
| Title | Change on Quality of Life |
|---|---|
| Description | The "Minnesota Living with Heart Failure Questionnaire" was used to assess quality of life (QOL). This scale has 21 questions and each question has a possible score of 0 - 5, where 0 is no or not applicable, 1 is very little and 5 is very much. The score for each question measures how much heart failure is affecting QOL. The higher the score the more heart failure is affecting QOL. Possible range of total scores is 0 - 105. The change from baseline QOL to quality of life at 12 months was calculated by subtracting the 12 month score from the baseline score. A lower score at 12 months indicates better QOL and a higher score at 12 months indicates a worse QOL. |
| Time Frame | Change from baseline quality of life at 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All in whom either Baseline or 12 month Quality of Life was assessed. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) Micronutrients: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at b |
| Measure Participants | 22 |
| Least Squares Mean (Standard Error) [units on a scale] |
2.6
(8.8)
|
| Title | Nutritional Status |
|---|---|
| Description | Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 6 months. |
| Time Frame | Change from baseline in nutritional status at 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All individuals with both baseline and 6 month assessment of nutritional status. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg) folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tab of ergocalciferol per week for two months followed by one tab every other week for four months, and Zinc Sulfate (Zn SO4) one tab daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) Micronutrients: Thiamin one tab daily provides 50 mg of thiamin, Vitamin B-50 one tab daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 IU tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Measure Participants | 20 |
| Median (Inter-Quartile Range) [score on a scale] |
0
|
| Title | Nutritional Status |
|---|---|
| Description | Nutritional Injury (NI) stage was used to assign nutritional status. Nutritional injury describes the interaction between agent, host and environmental factors as 6 progressive stages of altered nutritional status leading to nutritional disease. The 6 stages are seen as progressive beginning with (1) adaptation and diminishing or exceeding reserves, (2) reserves exhausted/ exceeded, (3) physiologic and metabolic alterations related to under/over nutrition, (4) non-specific signs and symptoms of under/over nutrition, (5) illness / specific signs and symptoms of under/over nutrition and (6) permanent damage/damage unresponsive to treatment. The following were used to determine overall nutritional status: body mass index, diet quality, blood nutrient levels and other biochemical measures, physical signs and symptoms of nutrient deficiencies or excesses. The lower the stage the less nutritional injury. The outcome measure is the difference in NI from baseline at 12 months. |
| Time Frame | Change from baseline in nutritional status at 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All individuals with both baseline and 12 month assessments of nutritional status. |
| Arm/Group Title | Micronutrients |
|---|---|
| Arm/Group Description | Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid & pyridoxine, 100 microgram (mcg) folic acid, & 50 mcg cyanocobalamin (B12) & biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) |
| Measure Participants | 15 |
| Median (Inter-Quartile Range) [score on a scale] |
0
|
Adverse Events
| Time Frame | The data was collected from the time of consent until the final visit, which occurred either six months or one year after starting the intervention. The protocol was amended to include data six months post-intervention, but not all participants continued on for the full year. | |
|---|---|---|
| Adverse Event Reporting Description | The adverse events were collected during patient visits. In the cases with abnormal lab values, select lab results (whole blood thiamin and plasma pyridoxine) were not available for up to two weeks following the visit. When the thiamin or pyridoxine were abnormal (defined as above the reference range) they reflected compliance with the study intervention not toxicity. | |
| Arm/Group Title | Micronutrients | |
| Arm/Group Description | Micronutrients: Thiamin 1 tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 1 tablet daily: provides 50 mg of thiamin, riboflavin, niacin, pantothenic acid & pyridoxine, 100 microgram (mcg) folic acid, & 50 mcg cyanocobalamin (B12) & biotin; Vitamin D 1 50,000 International Units(IU) tablet of ergocalciferol per week for 2 months followed by 1 tablet every other week for 4 months, and Zinc Sulfate (Zn SO4) 1 tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4) | |
All Cause Mortality |
||
| Micronutrients | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/22 (9.1%) | |
Serious Adverse Events |
||
| Micronutrients | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/22 (36.4%) | |
| Blood and lymphatic system disorders | ||
| Serious Adverse Event | 1/22 (4.5%) | 1 |
| Cardiac disorders | ||
| All Cause Mortality | 1/22 (4.5%) | 1 |
| All cause mortality | 1/22 (4.5%) | 1 |
| Serious Adverse Event | 1/22 (4.5%) | 2 |
| Gastrointestinal disorders | ||
| Adverse Events | 1/22 (4.5%) | 1 |
| General disorders | ||
| Serious Adverse Event | 1/22 (4.5%) | 1 |
| Infections and infestations | ||
| Serious Adverse Events | 1/22 (4.5%) | 3 |
| Serious Adverse Event | 1/22 (4.5%) | 1 |
| Serious Adverse Event | 1/22 (4.5%) | 1 |
| Vascular disorders | ||
| Serious Adverse Event | 1/22 (4.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Micronutrients | ||
| Affected / at Risk (%) | # Events | |
| Total | 16/22 (72.7%) | |
| Eye disorders | ||
| Other | 2/22 (9.1%) | 2 |
| Gastrointestinal disorders | ||
| Other | 2/22 (9.1%) | 2 |
| General disorders | ||
| Other | 2/22 (9.1%) | 2 |
| Metabolism and nutrition disorders | ||
| Other | 12/22 (54.5%) | 17 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Diane J. Parrington |
|---|---|
| Organization | Phoenix VA Health Care System |
| Phone | 602-277-5551 ext 7532 |
| diane.parrington@va.gov |
- Parrington 005