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Trial record 26 of 42 for:    " January 12, 2011":" February 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Vitamin D Supplements for HIV-positive Patients on cART

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ClinicalTrials.gov Identifier: NCT01295034
Recruitment Status : Completed
First Posted : February 14, 2011
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Andrea Branch, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-associated Co-morbidities
Interventions Dietary Supplement: conventional vitamin D treatment
Drug: tiered/titrated vitamin D dosing
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Conventional Vitamin D Treatment Tiered/Titrated Vitamin D Dosing
Hide Arm/Group Description 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: 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.
Period Title: Overall Study
Started 32 30
Completed 27 25
Not Completed 5 5
Reason Not Completed
Lost to Follow-up             5             5
Arm/Group Title Conventional Vitamin B Dosing Tiered/Titrated Vitamin B Dosing Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 32 30 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
 100.0%
30
 100.0%
62
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 32 participants 30 participants 62 participants
47
(39 to 51)
48
(42 to 52)
48
(41 to 51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 62 participants
Female
7
  21.9%
6
  20.0%
13
  21.0%
Male
25
  78.1%
24
  80.0%
49
  79.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 30 participants 62 participants
32 30 62
1.Primary Outcome
Title 25(OH)D Levels
Hide Description 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.
Time Frame baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Vitamin D Treatment Tiered/Titrated Vitamin D Dosing
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 32 30
Measure Type: Count of Participants
Unit of Measure: Participants
13
  40.6%
20
  66.7%
2.Secondary Outcome
Title CD4+T Cell Count
Hide Description The change in the CD4+T cell count between the two arms.
Time Frame baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis only for participants who completed the study.
Arm/Group Title Conventional Vitamin B Dosing Tiered/Titrated Vitamin D Dosing
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 27 23
Median (Inter-Quartile Range)
Unit of Measure: cell/μL
26
(-56 to 122)
40
(-45 to 65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Vitamin B Dosing Tiered/Titrated Vitamin B Dosing
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Conventional Vitamin B Dosing Tiered/Titrated Vitamin B Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Vitamin B Dosing Tiered/Titrated Vitamin B Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conventional Vitamin B Dosing Tiered/Titrated Vitamin B Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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: Andrea D. Branch PhD
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212 659 8371
Responsible Party: Andrea Branch, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01295034     History of Changes
Other Study ID Numbers: GCO 10-0679
R01DA031095 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2011
First Posted: February 14, 2011
Results First Submitted: March 6, 2017
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017