Trial Outcomes & Findings for Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors (NCT NCT01509079)
NCT ID: NCT01509079
Last Updated: 2019-06-18
Results Overview
The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
baseline to 6 months
Results posted on
2019-06-18
Participant Flow
Participant milestones
| Measure |
Vitamin D3 4000 IU
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
59
|
|
Overall Study
COMPLETED
|
57
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Vitamin D3 4000 IU
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
started an excluded medication
|
0
|
1
|
Baseline Characteristics
Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Baseline characteristics by cohort
| Measure |
Vitamin D3 4000 IU
n=57 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=56 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
60.3 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
60.9 years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=93 Participants
|
56 participants
n=4 Participants
|
113 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 monthsPopulation: Only participants who provided data at both time points are included
The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia
Outcome measures
| Measure |
Vitamin D3 4000 IU
n=57 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=55 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale
|
-0.2 units on a scale
Standard Deviation 0.7
|
-0.5 units on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: baseline to 6 monthsPopulation: only data from participants that were collected at both time points is included
Outcome measures
| Measure |
Vitamin D3 4000 IU
n=54 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=53 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Change in Hand Grip Strength
|
1.8 pounds
Standard Deviation 10.6
|
1.0 pounds
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: only data from participants with measures at both time points are included
PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).
Outcome measures
| Measure |
Vitamin D3 4000 IU
n=57 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=55 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Change in PROMIS Physical Functioning Questionnaire
|
0.6 units on a scale
Standard Deviation 4.9
|
1.7 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 monthsadherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months
Outcome measures
| Measure |
Vitamin D3 4000 IU
n=57 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=56 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Average Percent Adherence to Vitamin D Interventio
|
95 % of adherence for each treatment arm
|
95 % of adherence for each treatment arm
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: only participants whose serum was obtained at both time points are included
Outcome measures
| Measure |
Vitamin D3 4000 IU
n=52 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=50 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Serum Estradiol Concentrations
Baseline
|
2.83 pg/ml
Standard Error 0.1
|
2.77 pg/ml
Standard Error 0.1
|
|
Serum Estradiol Concentrations
6 months
|
2.94 pg/ml
Standard Error 0.16
|
3.0 pg/ml
Standard Error 0.12
|
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: Only study participants with baseline and 6 month blood samples available were analyzed
Difference in steady state concentrations in plasma from baseline to 6 months
Outcome measures
| Measure |
Vitamin D3 4000 IU
n=47 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=48 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Change in Steady State Concentrations of Serum Anastrazole and Letrozole
anastrozole
|
-1.31 mg/L
Standard Deviation 10.67
|
2.4 mg/L
Standard Deviation 5.36
|
|
Change in Steady State Concentrations of Serum Anastrazole and Letrozole
letrozole
|
2.16 mg/L
Standard Deviation 9.69
|
-0.83 mg/L
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: From Baseline and 6 months of D3 supplementationGLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use
Outcome measures
| Measure |
Vitamin D3 4000 IU
n=53 Participants
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=54 Participants
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Whole Body Bone Mineral Density
|
1.1 gm/cm2
Standard Deviation 0.12
|
1.12 gm/cm2
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: BaselinePopulation: Due to funding limitations, this secondary aim was not collected and analyzed in these groups
Outcome measures
Outcome data not reported
Adverse Events
Vitamin D3 4000 IU
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Vitamin D3 600 IU
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D3 4000 IU
n=57 participants at risk
Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
|
Vitamin D3 600 IU
n=56 participants at risk
Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
17.5%
10/57
Adverse events were collected with regard to the organ system
|
17.9%
10/56
Adverse events were collected with regard to the organ system
|
|
Gastrointestinal disorders
Gastrointestinal complaints
|
21.1%
12/57
Adverse events were collected with regard to the organ system
|
12.5%
7/56
Adverse events were collected with regard to the organ system
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
8.8%
5/57
Adverse events were collected with regard to the organ system
|
5.4%
3/56
Adverse events were collected with regard to the organ system
|
|
Surgical and medical procedures
Surgical and medical procedures
|
7.0%
4/57
Adverse events were collected with regard to the organ system
|
1.8%
1/56
Adverse events were collected with regard to the organ system
|
|
Nervous system disorders
Nervous system disorders
|
12.3%
7/57
Adverse events were collected with regard to the organ system
|
5.4%
3/56
Adverse events were collected with regard to the organ system
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
15.8%
9/57
Adverse events were collected with regard to the organ system
|
5.4%
3/56
Adverse events were collected with regard to the organ system
|
|
Skin and subcutaneous tissue disorders
Skin problems
|
8.8%
5/57
Adverse events were collected with regard to the organ system
|
8.9%
5/56
Adverse events were collected with regard to the organ system
|
|
Cardiac disorders
Cardiac
|
3.5%
2/57
Adverse events were collected with regard to the organ system
|
5.4%
3/56
Adverse events were collected with regard to the organ system
|
|
General disorders
General
|
5.3%
3/57
Adverse events were collected with regard to the organ system
|
1.8%
1/56
Adverse events were collected with regard to the organ system
|
|
Reproductive system and breast disorders
Reproductive and breast issues
|
3.5%
2/57
Adverse events were collected with regard to the organ system
|
8.9%
5/56
Adverse events were collected with regard to the organ system
|
|
Injury, poisoning and procedural complications
Injuries
|
5.3%
3/57
Adverse events were collected with regard to the organ system
|
7.1%
4/56
Adverse events were collected with regard to the organ system
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place