Trial Outcomes & Findings for Vitamin D HIV Study on Postmenopausal Women (NCT NCT01375010)
NCT ID: NCT01375010
Last Updated: 2019-03-07
Results Overview
Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Baseline, 12 months
Results posted on
2019-03-07
Participant Flow
Participant milestones
| Measure |
Group A
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
COMPLETED
|
31
|
38
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
Reasons for withdrawal
| Measure |
Group A
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Vitamin D HIV Study on Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Group A
n=43 Participants
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=42 Participants
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 4.9 • n=39 Participants
|
56.5 years
STANDARD_DEVIATION 5.6 • n=41 Participants
|
56.3 years
STANDARD_DEVIATION 5.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
85 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
African American
|
17 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
26 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: A complete case approach was utilized for outcome in participants with BMD data at 12 months (n=69).
Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months
Outcome measures
| Measure |
Group A
n=31 Participants
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=38 Participants
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Change in Bone Mineral Density (BMD)
|
0.4 percentage change
Standard Deviation 4.4
|
-0.8 percentage change
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline,12 monthsPopulation: A complete case approach was utilized for outcome in participants with BMD data at 12 months (n=69).
To evaluate the change in areal BMD (aBMD) at the total hip (TH)
Outcome measures
| Measure |
Group A
n=31 Participants
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=38 Participants
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Areal Change in Bone Mineral Density (aBMD)
|
-0.5 percentage of change
Standard Deviation 3.1
|
-0.8 percentage of change
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: A complete case approach was utilized for secondary outcomes in participants with vBMD data at 12 months (n=69).
To evaluate the change in volumetric BMD (VBMD) at the Tibia
Outcome measures
| Measure |
Group A
n=31 Participants
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=38 Participants
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Change in Volumetric Bone Mineral Density (vBMD)
|
-0.3 percentage of change
Standard Deviation 2.9
|
-0.9 percentage of change
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: A complete case approach was utilized for secondary outcomes in participants with data at 12 months (n=69).
To evaluate the change in vitamin D levels with supplementation
Outcome measures
| Measure |
Group A
n=31 Participants
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=38 Participants
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Change in Vitamin D Levels
|
33.7 percentage of change
Standard Deviation 41.9
|
64.1 percentage of change
Standard Deviation 68.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: A complete case approach was utilized for secondary outcomes in participants with data at 12 months (n=69).
To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation. (PTH)
Outcome measures
| Measure |
Group A
n=31 Participants
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=38 Participants
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Change in Biochemical Markers
|
-7.2 percentage of change
Standard Deviation 71.4
|
-16.8 percentage of change
Standard Deviation 33.0
|
Adverse Events
Group A
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Group B
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=43 participants at risk
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=42 participants at risk
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
Gastrointestinal disorders
Rectal bleeding/ hemorrhage
|
2.3%
1/43 • Number of events 1 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
0.00%
0/42 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
|
Cardiac disorders
Cardiac Ischemia
|
0.00%
0/43 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
2.4%
1/42 • Number of events 1 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
Other adverse events
| Measure |
Group A
n=43 participants at risk
Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU.
Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
Group B
n=42 participants at risk
2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Vitamin D3: 2000 mg QD
Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
|
|---|---|---|
|
General disorders
Pain
|
4.7%
2/43 • Number of events 3 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
4.8%
2/42 • Number of events 2 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43 • Number of events 3 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
0.00%
0/42 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
|
Renal and urinary disorders
Kidney Stones
|
4.7%
2/43 • Number of events 2 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
7.1%
3/42 • Number of events 3 • 1 year
Adverse event reporting was collected at every visit as part of the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place