CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
tiered/titrated vitamin D dosing +1 moredrug
Likely dose
tiered/titrated vitamin D dosing 4000 IUfrom record
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Search/NCT01295034
NCT01295034N/ACompleted
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Vitamin D Supplements for HIV-positive Patients on cART

Andrea Branch·interventional·Posted Feb 14, 2011·Updated Apr 17, 2017

In Brief

A clinical study evaluating conventional vitamin D treatment and tiered/titrated vitamin D dosing for HIV-associated Co-morbidities. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-associated Co-morbidities
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 14, 2011
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.4 years ago

Interventions

conventional vitamin D treatmentdietary

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 dosingdrug

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.