Trial Outcomes & Findings for Individualized Response to Vitamin D Treatment Study (NCT NCT02925195)
NCT ID: NCT02925195
Last Updated: 2023-11-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
666 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-11-02
Participant Flow
Participant milestones
| Measure |
Active Treatment
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
499
|
167
|
|
Overall Study
COMPLETED
|
453
|
158
|
|
Overall Study
NOT COMPLETED
|
46
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individualized Response to Vitamin D Treatment Study
Baseline characteristics by cohort
| Measure |
Active Treatment
n=499 Participants
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 Participants
Placebo
|
Total
n=666 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 8 • n=5 Participants
|
72 years
STANDARD_DEVIATION 8 • n=7 Participants
|
72 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
227 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
169 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
184 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
64 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
82 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Active Treatment
n=499 Participants
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 Participants
Placebo
|
|---|---|---|
|
Change in Serum 1,25(OH)2D Concentration
|
2 pg/mL
Standard Deviation 16
|
-1 pg/mL
Standard Deviation 17
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Active Treatment
n=499 Participants
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 Participants
Placebo
|
|---|---|---|
|
Change in Serum PTH Concentration
|
-3 pg/mL
Standard Deviation 16
|
2 pg/mL
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Active Treatment
n=499 Participants
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 Participants
Placebo
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-3 mmHg
Standard Deviation 18
|
-4 mmHg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 16 weeksUrine calcium excretion estimated as spot urine calcium-creatinine ratio
Outcome measures
| Measure |
Active Treatment
n=499 Participants
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 Participants
Placebo
|
|---|---|---|
|
Change in Urine Calcium Excretion
|
8 mg per g of creatinine
Standard Deviation 83
|
1 mg per g of creatinine
Standard Deviation 70
|
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Active Treatment
n=499 Participants
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 Participants
Placebo
|
|---|---|---|
|
Change in Serum Calcium Concentrations
|
0 mg/dL
Standard Deviation 0.3
|
0 mg/dL
Standard Deviation 0.3
|
Adverse Events
Active Treatment
Serious events: 2 serious events
Other events: 55 other events
Deaths: 1 deaths
Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Treatment
n=499 participants at risk
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 participants at risk
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diverticulosis
|
0.00%
0/499 • 16 weeks
|
0.60%
1/167 • Number of events 1 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
1/499 • Number of events 1 • 16 weeks
|
0.00%
0/167 • 16 weeks
|
|
General disorders
Death
|
0.20%
1/499 • Number of events 1 • 16 weeks
|
0.00%
0/167 • 16 weeks
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/499 • 16 weeks
|
0.60%
1/167 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Active Treatment
n=499 participants at risk
Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily
|
Placebo
n=167 participants at risk
Placebo
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
1.0%
5/499 • Number of events 5 • 16 weeks
|
0.60%
1/167 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
4.4%
22/499 • Number of events 22 • 16 weeks
|
3.6%
6/167 • Number of events 6 • 16 weeks
|
|
General disorders
General disorders and administration site conditions
|
1.6%
8/499 • Number of events 8 • 16 weeks
|
0.60%
1/167 • Number of events 1 • 16 weeks
|
|
Immune system disorders
Immune system disorders
|
1.6%
8/499 • Number of events 8 • 16 weeks
|
1.2%
2/167 • Number of events 2 • 16 weeks
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.40%
2/499 • Number of events 2 • 16 weeks
|
0.60%
1/167 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, connective tissue, and bone disorders
|
1.0%
5/499 • Number of events 5 • 16 weeks
|
1.2%
2/167 • Number of events 2 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified
|
0.20%
1/499 • Number of events 1 • 16 weeks
|
0.00%
0/167 • 16 weeks
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/499 • 16 weeks
|
0.60%
1/167 • Number of events 1 • 16 weeks
|
|
Renal and urinary disorders
Renal and urinary tract disorders
|
0.20%
1/499 • Number of events 1 • 16 weeks
|
1.2%
2/167 • Number of events 2 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
0.40%
2/499 • Number of events 2 • 16 weeks
|
0.00%
0/167 • 16 weeks
|
|
General disorders
|
0.20%
1/499 • Number of events 1 • 16 weeks
|
0.00%
0/167 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place