Vitamin D Supplements for HIV-positive Patients on cART
2 other identifiers
interventional
62
1 country
1
Brief Summary
The ability of vitamin D to modulate the immune system and strengthen bones may mitigate the adverse medication consequences of HIV/AIDS, but little is known about either the health benefits of vitamin D supplements, or about the optimal dosing regimen for patients on highly active antiretroviral therapy (HAART). This trial is a comparison of two regimens for administering vitamin D and calcium to HIV-positive individuals taking antiviral medications. This study will help physicians make evidence-based decisions about the most effective way to use vitamin D in their patients and enable the design of large multi-center trials in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
April 17, 2017
CompletedApril 17, 2017
March 1, 2017
4.3 years
February 10, 2011
March 6, 2017
March 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
25(OH)D Levels
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.
baseline and 12 months
Secondary Outcomes (1)
CD4+T Cell Count
baseline and 12 months
Study Arms (2)
conventional vitamin D treatment
PLACEBO COMPARATORSubjects 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
EXPERIMENTALSubjects in Protocol B will receive 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.
Interventions
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.
Subjects in Protocol B will receive 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.
Eligibility Criteria
You may qualify if:
- age, 18-70 yr
- HIV-infected
- on a stable HAART regimen for at least 12 mo with an undetectable HIV viral load for 6-mo
- willing to participate
- not receiving vitamin D supplementation in a form other than vitamin D2 or vitamin D3
- not receiving treatment for bone disease
- not receiving medications known to alter bone mineralization
- not suffering from conditions known to affect vitamin D, calcium, and/or phosphate levels (including clinically significant hypocalcemia, primary hyperparathyroidism)
- not experiencing kidney disease based on GFR \> 60 min/ml/1.73 m2, 10) 25(OH)D level \< 25 ng/ml
- not meeting criteria of the National Osteoporosis Foundation for established bone disease (osteoporosis, osteomalacia) requiring immediate treatment
- not consuming more than 2.0 gm of calcium/day in food and supplements combined outside the trial
- not consuming more than 800IU/day of vitamin D outside the trial
- not suffering from an unstable medical condition likely to preclude participation in a 12 month trial
- able to ingest and absorb food and nutrients
- not pregnant or planning to become pregnant.
You may not qualify if:
- No history or evidence of HIV infection
- HIV viral load positive
- outside the age range
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrea Branchlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Icahn School of Medicine Mount Sinai
New York, New York, 10029, United States
Related Publications (1)
McComsey GA, Tebas P, Shane E, Yin MT, Overton ET, Huang JS, Aldrovandi GM, Cardoso SW, Santana JL, Brown TT. Bone disease in HIV infection: a practical review and recommendations for HIV care providers. Clin Infect Dis. 2010 Oct 15;51(8):937-46. doi: 10.1086/656412.
PMID: 20839968BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrea D. Branch PhD
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea D Branch, PhD
Icahn School of Medicine Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 14, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
April 17, 2017
Results First Posted
April 17, 2017
Record last verified: 2017-03