Trial Outcomes & Findings for Vitamin D Supplements for HIV-positive Patients on cART (NCT NCT01295034)
NCT ID: NCT01295034
Last Updated: 2017-04-17
Results Overview
The difference in the percentage of subjects with 25(OH)D levels in the range of 30-60 ng/ml at 12 mo between the two arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
baseline and 12 months
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
Conventional Vitamin D Treatment
conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
|
Tiered/Titrated Vitamin D Dosing
tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
COMPLETED
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Conventional Vitamin D Treatment
conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
|
Tiered/Titrated Vitamin D Dosing
tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
Vitamin D Supplements for HIV-positive Patients on cART
Baseline characteristics by cohort
| Measure |
Conventional Vitamin B Dosing
n=32 Participants
Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
|
Tiered/Titrated Vitamin B Dosing
n=30 Participants
tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
47 years
n=93 Participants
|
48 years
n=4 Participants
|
48 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
30 participants
n=4 Participants
|
62 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 monthsThe difference in the percentage of subjects with 25(OH)D levels in the range of 30-60 ng/ml at 12 mo between the two arms.
Outcome measures
| Measure |
Conventional Vitamin D Treatment
n=32 Participants
conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
|
Tiered/Titrated Vitamin D Dosing
n=30 Participants
tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
|
|---|---|---|
|
25(OH)D Levels
|
13 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: Analysis only for participants who completed the study.
The change in the CD4+T cell count between the two arms.
Outcome measures
| Measure |
Conventional Vitamin D Treatment
n=27 Participants
conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
|
Tiered/Titrated Vitamin D Dosing
n=23 Participants
tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
|
|---|---|---|
|
CD4+T Cell Count
|
26 cell/μL
Interval -56.0 to 122.0
|
40 cell/μL
Interval -45.0 to 65.0
|
Adverse Events
Conventional Vitamin B Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tiered/Titrated Vitamin B Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrea D. Branch PhD
Icahn School of Medicine at Mount Sinai
Phone: 212 659 8371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place