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Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)

Sponsor
Loyola University (Other)
Overall Status
Completed
CT.gov ID
NCT02186015
Collaborator
(none)
43
Enrollment
1
Location
2
Arms
33.2
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: Several clinical trials are underway to investigate if variable forms of vitamin D (D2 vs. D3) prescribed at different doses (10,000-50,000 IUs/week) can improve the side-effects associated with treatment for estrogen receptor positive (ER+) breast cancer, specifically aromatase inhibitors (AIs.) Presumably for generalizability and potential safety purposes, these trials predominantly exclude women with metastatic breast cancer (MBC); a rapidly expanding sector of the cancer survivor population who experience significant treatment-related side-effects. Evaluation of the safety of vitamin D3 supplementation is crucial since supplementation can lead to high calcium and importantly, in lab studies have shown that vitamin D3 affects a gene that increases estrogen production. To assure that vitamin D3 does not affect the clinical effects of anti-estrogen therapies, the effect of vitamin D3 supplements on estrogen production requires an evaluation that further explores and defines its potential role in symptom management for this population.

Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in women with MBC, providing much needed data on the preliminary safety and efficacy of this treatment in this patient population. This study will determine: 1) if weekly supplementation of high dose vitamin D3 increases serum vitamin D levels without adverse effects related to such therapy (primary aim); 2) the effects of vitamin D3 supplementation on symptom management (secondary aim); and 3) if vitamin D3 supplementation is associated with improved inflammation (exploratory aim.)

Methods: This is an 8 week "proof of concept" study to monitor laboratory parameters and to assess potential effects on short-term outcomes. Adult, female patients (>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D < 30 mg/dl will be recruited from within and around LUMC. Following current clinical practice guidelines, eligible participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks. Laboratory values, muscle function and inflammation will be examined pre- and post-supplementation, while symptoms will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if increases in vitamin D are associated with clinically significant improvements in symptoms and QOL, and decreased inflammation.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Study Aims

Several clinical trials are underway to investigate if vitamin D2 or D3 provided at various doses (10,000-50,000 IUs/week) can improve the side-effects associated with anti-estrogen therapies, specifically aromatase inhibitors (AIs). However, these current trials use variable forms of vitamin D and predominantly include women with Stage I-III disease, excluding women with metastatic breast cancer. Evaluation of the safety of vitamin D3 supplementation is crucial since supplementation can lead to hypercalcemia and importantly, in vitro studies have shown that vitamin D3 influences the transcription of a gene that increases estrogen production.27,28 To assure that vitamin D3 does not abrogate the clinical effects of anti-estrogen therapies, the effect of vitamin D3 supplementation on estrogen production requires evaluation. Therefore, the overarching goal of this pilot study is to evaluate the safety, feasibility and efficacy of vitamin D3 supplementation in women with

MBC. We will address and test the following aims and hypotheses, respectively:

Aim 1: To determine if weekly supplementation of 50,000 IUs of vitamin D3 raises serum levels of 25(OH)D to >30 mg/dl without adverse effects.

Hypothesis 1: Women who are compliant with vitamin D3 supplementation, as evidenced by normalization (>30 mg/dl) or increases in their serum 25(OH)D levels, will not experience significant changes in serum calcium, parathyroid hormone or serum estradiol levels.

Aim 2: To determine the effect of vitamin D3 supplementation on symptom management.

Hypothesis 2: Women who achieve serum concentrations of 25 (OH)D ≥30 mg/dl or experience significant increases in 25(OH)D will exhibit improvements in pain, fatigue, sleep, mood, muscle function and overall quality of life.

Exploratory Aim: To explore the mechanistic effects of vitamin D3 supplementation on inflammatory markers and its potential association with symptom management.

Summary: Evidence from studies involving early stage breast cancer participants confirms that musculoskeletal pain, endocrine related symptoms and mood disturbances are commonly associated with breast cancer treatment, particularly hormone deprivation therapies. The high prevalence of vitamin D deficiency/insufficiency among breast cancer survivors is well accepted and further hypothesized to aggravate treatment-related side effects, particularly arthralgias. Women with MBC are excluded from the majority of on-going vitamin D supplementation trials for safety and generalizability purposes. However, novel therapies are continuing to improve and prolong the lives of these women, resulting in a rapidly expansive group of breast cancer survivors. While vitamin D supplementation is prescribed to correct an underlying nutrient deficiency in the clinical context of preserving bone health, emerging evidence suggests it may have more systemic effects. Thus, vitamin D repletion/supplementation has profound potential implications for women with MBC, whose primary goal of treatment is to minimize the side-effects of treatment in support of optimal quality of life. This study reflects a highly innovative, yet simple therapy that could ultimately provide these survivors with a much needed evidence-based supportive care strategies.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D)
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Mar 8, 2017
Actual Study Completion Date :
Nov 9, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cholecalciferol

All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.

Drug: Cholecalciferol
Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.
Other Names:
  • Vitamin D3
  • Vitamin D

    		•
    No Intervention: Vitamin D sufficient

    All participants were ineligible for the intervention due to sufficient serum 25(OH)D levels at screening/baseline.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Serum 25(OH)D [0, 8 weeks]

      Change in laboratory serum value of 25(OH)D at 8 weeks post-supplementation for participants who received weekly supplementation of 50,000 IUs of vitamin D3. Change is expressed as laboratory serum value of 25(OH)D at 8 weeks minus baseline. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    Secondary Outcome Measures

    1. Change in Worst Pain Rating From the Beck Pain Scale [0, 8 weeks]

      Assessment of pain using the Beck Pain Scale at weeks 0 and 8. This is a Likert scale item where a score of 0 corresponds to no pain and a score of 10 corresponds to worst pain. Change is calculated as the worst pain rating at 8 weeks minus the worst pain rating at 0 weeks.Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    2. Change in Fatigue [0, 8 weeks]

      Assessment of fatigue using the Piper Fatigue Scale at weeks 0 and 8. The Piper Fatigue Scale is the average of 22 numeric items, with higher scores indicating greater fatigue [range of scores: 0-10]. Change is calculated as the fatigue score at 8 weeks minus fatigue score at 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    3. Change in Mood [0, 8 weeks]

      Assessment of mood using the Patient Health Questionnaire 8 (PHQ-8) at weeks 0 and 8. The PHQ-8 ranges from 0-24 with higher scores indicating more distress. Change was assessed as PHQ-8 score at 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    4. Change in Muscle Function [0, 8 weeks]

      Assessment of muscle function using a hand dynamometer at weeks 0 and 8. Change in dominant handgrip strength in kilograms was calculated as 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    5. Change in Sleep Quality Assessment [0, 8 weeks]

      Assessment of sleep using the Pittsburgh Sleep Quality Index (PSQI) at weeks 0 and 8. Scores range from 0-21 with higher scores indicating poorer sleep quality. Change was calculated as week 8 minus week 0 PSQI. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    6. Change in Functional Assessment of Cancer Therapy-breast [0, 8 weeks]

      Assessment of quality of life using the functional assessment of cancer therapy-breast symptoms at weeks 0 and 8. Scores range from 0-40 with higher scores indicating better quality of life. Change was calculated as week 8 score minus week 0 score. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    7. Change in Functional Assessment of Cancer Therapy-endocrine [0, 8 weeks]

      Assessment of quality of life using the functional assessment of cancer therapy- endocrine symptoms at weeks 0 and 8. Scores range from 0-76 with higher scores indicating better quality of life. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Metastatic breast cancer (Stage IV)

    2. Histologically confirmed estrogen receptor positive disease

    3. Female

    4. Serum 25(OH) <30 ng/ml

    5. Age ≥ 18 years

    6. Pre or post-menopausal

    7. ECOG Performance status 0-2

    8. Adequate organ function as defined as GFR> 30 mls/min and serum calcium ≤ 10.4 mg/dl

    9. Any race/ethnicity

    10. English speaking

    11. No changes to MBC treatments within 30 days of enrollment and/or deemed clinically stable by their treating physician

    12. Willingness to sign a written informed consent and complete questionnaires

    13. Cease ingestion of vitamin D supplementation not study related

    Exclusion Criteria:

    1. Women with Stage I-III breast cancer

    2. Serum 25(OH)D levels ≥ 30 ng/ml

    3. Untreated CNS involvement

    4. History of kidney stones

    5. History of renal failure

    6. History of hyperparathyroidism

    7. History of hypersensitivity to vitamin D

    8. Non-English speaking

    9. Currently pregnant or lactating, or anticipating pregnancy

    10. Unwilling to cease ingestion of calcium supplements (>1000 mg/d)

    11. Unwilling or unable to complete informed consent or study questionnaires

    12. Psychiatric or other clinical conditions that preclude study compliance

    13. Other important medical or safety considerations at the discretion of the investigator and/or study physician, including non-compliance with the study therapy or other activities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loyola University Medical Center Maywood Illinois United States 60153

    Sponsors and Collaborators

    • Loyola University

    Investigators

    • Principal Investigator: Patricia M Sheean, Ph.D., R.D., Loyola University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Patricia Sheean, Research Associate, Loyola University
    ClinicalTrials.gov Identifier:
    NCT02186015
    Other Study ID Numbers:
    • 206519
    First Posted:
    Jul 10, 2014
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Patricia Sheean, Research Associate, Loyola University
    Metastatic Breast Cancer
    MBC
    Vitamin D Supplementation
    Symptom Management
    Additional relevant MeSH terms:
    Breast Neoplasms
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited from a single cancer center and required to be: 1) >18 years of age, 2) English speaking, 3) at a performance status of 0-2, 4) receiving treatment for histologically confirmed ER+ metastatic BC, and 5) clinically stable as judged by their medical oncologist.
    Pre-assignment Detail
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Period Title: Overall Study
    STARTED 11 31
    COMPLETED 10 31
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Cholecalciferol No Cholecalciferol Total
    Arm/Group Description Enrolled women with serum 25 (OH)D less than 30 ng/ml received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention. Total of all reporting groups
    Overall Participants 11 31 42
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    10
    90.9%
    20
    64.5%
    30
    71.4%
    >=65 years
    1
    9.1%
    11
    35.5%
    12
    28.6%
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    57
    63
    62
    Sex: Female, Male (Count of Participants)
    Female
    11
    100%
    31
    100%
    42
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Non-Hispanic White
    5
    45.5%
    26
    83.9%
    31
    73.8%
    Black
    4
    36.4%
    0
    0%
    4
    9.5%
    Hispanic
    2
    18.2%
    4
    12.9%
    6
    14.3%
    Other
    0
    0%
    1
    3.2%
    1
    2.4%
    Region of Enrollment (Count of Participants)
    United States
    11
    100%
    31
    100%
    42
    100%
    Employment status (Count of Participants)
    Paid full- or part-time work
    6
    54.5%
    12
    38.7%
    18
    42.9%
    Retired without disability
    1
    9.1%
    12
    38.7%
    13
    31%
    Retired with disability
    2
    18.2%
    6
    19.4%
    8
    19%
    Unemployed
    2
    18.2%
    1
    3.2%
    3
    7.1%
    Body mass index (kg/m^2) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [kg/m^2]
    27.3
    27.8
    27.5
    Stage IV at diagnosis (Count of Participants)
    Yes
    4
    36.4%
    8
    25.8%
    12
    28.6%
    No
    7
    63.6%
    23
    74.2%
    30
    71.4%
    Duration of metastatic breast cancer (months) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [months]
    7
    19
    13
    Metastatic sites (Count of Participants)
    1 or 2
    9
    81.8%
    25
    80.6%
    34
    81%
    Greater than 2
    2
    18.2%
    6
    19.4%
    8
    19%
    Eastern Cooperative Oncology Group (Count of Participants)
    0
    5
    45.5%
    11
    35.5%
    16
    38.1%
    1
    6
    54.5%
    19
    61.3%
    25
    59.5%
    2
    0
    0%
    1
    3.2%
    1
    2.4%
    Radiation therapy for metastates (Count of Participants)
    Yes
    3
    27.3%
    10
    32.3%
    13
    31%
    No
    8
    72.7%
    21
    67.7%
    29
    69%
    Surgery for breast cancer (Count of Participants)
    None
    6
    54.5%
    5
    16.1%
    11
    26.2%
    Lumpectomy
    4
    36.4%
    14
    45.2%
    18
    42.9%
    Mastectomy
    1
    9.1%
    12
    38.7%
    13
    31%
    Serum 25(OH)D (ng/ml) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [ng/ml]
    17
    38
    34

    Outcome Measures

    1. Primary Outcome
    Title Change in Serum 25(OH)D
    Description Change in laboratory serum value of 25(OH)D at 8 weeks post-supplementation for participants who received weekly supplementation of 50,000 IUs of vitamin D3. Change is expressed as laboratory serum value of 25(OH)D at 8 weeks minus baseline. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did not have laboratory serum value of 25(OH)D at week 8. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [ng/ml]
    32
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in serum 25(OH)D from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments A Wilcoxon signed rank test was performed.
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method Wilcoxon signed rank test
    Comments
    2. Secondary Outcome
    Title Change in Worst Pain Rating From the Beck Pain Scale
    Description Assessment of pain using the Beck Pain Scale at weeks 0 and 8. This is a Likert scale item where a score of 0 corresponds to no pain and a score of 10 corresponds to worst pain. Change is calculated as the worst pain rating at 8 weeks minus the worst pain rating at 0 weeks.Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did not have laboratory serum value of 25(OH)D at week 8. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [score on a scale]
    0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in worst pain rating from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments A Wilcoxon signed rank test was performed.
    Statistical Test of Hypothesis p-Value 0.24
    Comments
    Method Wilcoxon signed rank test
    Comments
    3. Secondary Outcome
    Title Change in Fatigue
    Description Assessment of fatigue using the Piper Fatigue Scale at weeks 0 and 8. The Piper Fatigue Scale is the average of 22 numeric items, with higher scores indicating greater fatigue [range of scores: 0-10]. Change is calculated as the fatigue score at 8 weeks minus fatigue score at 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did not have assessment of fatigue at week 8. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [units on a scale]
    -0.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in fatigue score from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.09
    Comments
    Method Wilcoxon signed rank test
    Comments
    4. Secondary Outcome
    Title Change in Mood
    Description Assessment of mood using the Patient Health Questionnaire 8 (PHQ-8) at weeks 0 and 8. The PHQ-8 ranges from 0-24 with higher scores indicating more distress. Change was assessed as PHQ-8 score at 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did not have assessment of mood at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [score on a scale]
    -1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in mood score from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.17
    Comments
    Method Wilcoxon signed rank test
    Comments
    5. Secondary Outcome
    Title Change in Muscle Function
    Description Assessment of muscle function using a hand dynamometer at weeks 0 and 8. Change in dominant handgrip strength in kilograms was calculated as 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did not have hand dynamometer data at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [kilograms]
    -0.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in dominant handgrip strength from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.50
    Comments
    Method Wilcoxon signed rank test
    Comments
    6. Secondary Outcome
    Title Change in Sleep Quality Assessment
    Description Assessment of sleep using the Pittsburgh Sleep Quality Index (PSQI) at weeks 0 and 8. Scores range from 0-21 with higher scores indicating poorer sleep quality. Change was calculated as week 8 minus week 0 PSQI. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did report the Pittsburgh Sleep Quality Index at week 8. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [score on a scale]
    -1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in sleep quality assessment from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments
    Method Wilcoxon signed rank test
    Comments
    7. Secondary Outcome
    Title Change in Functional Assessment of Cancer Therapy-breast
    Description Assessment of quality of life using the functional assessment of cancer therapy-breast symptoms at weeks 0 and 8. Scores range from 0-40 with higher scores indicating better quality of life. Change was calculated as week 8 score minus week 0 score. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did not have the Functional assessment of cancer therapy-breast at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [score on a scale]
    0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in functional assessment of cancer therapy-breast score from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.75
    Comments
    Method Wilcoxon signed rank test
    Comments
    8. Secondary Outcome
    Title Change in Functional Assessment of Cancer Therapy-endocrine
    Description Assessment of quality of life using the functional assessment of cancer therapy- endocrine symptoms at weeks 0 and 8. Scores range from 0-76 with higher scores indicating better quality of life. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time.
    Time Frame 0, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    1 participant who initiated supplementation of cholecalciferol did not have the Functional assessment of cancer therapy-endocrine at 8 weeks. Follow up laboratory and/or questionnaire data were not collected for women in the 'no cholecalciferol' arm.
    Arm/Group Title Cholecalciferol No Cholecalciferol
    Arm/Group Description All participants will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Cholecalciferol: Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks. Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    Measure Participants 10 0
    Median (Inter-Quartile Range) [score on a scale]
    9
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cholecalciferol
    Comments The null hypothesis is that there is 0 change in functional assessment of cancer therapy-endocrine score from week 0 to week 8.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.19
    Comments
    Method Wilcoxon signed rank test
    Comments

    Adverse Events

    Time Frame 8 weeks
    Adverse Event Reporting Description
    Arm/Group Title Intervention No Intervention
    Arm/Group Description Enrolled women with serum 25 (OH)D less than 30 ng/ml received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks Enrolled women without serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention.
    All Cause Mortality
    Intervention No Intervention
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/11 (0%) 0/31 (0%)
    Serious Adverse Events
    Intervention No Intervention
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/11 (0%) 0/31 (0%)
    Other (Not Including Serious) Adverse Events
    Intervention No Intervention
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/11 (27.3%) 0/31 (0%)
    Gastrointestinal disorders
    Nausea 3/11 (27.3%) 3 0/31 (0%) 3
    Infections and infestations
    Upper respiratory infection 2/11 (18.2%) 2 0/31 (0%) 2

    Limitations/Caveats

    [Not Specified]

    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 Patricia Sheean
    Organization Loyola University Chicago
    Phone 708-216-0344
    Email psheean1@luc.edu
    Responsible Party:
    Patricia Sheean, Research Associate, Loyola University
    ClinicalTrials.gov Identifier:
    NCT02186015
    Other Study ID Numbers:
    • 206519
    First Posted:
    Jul 10, 2014
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021