CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Cholecalciferol (Vit D3)drug
Likely dose
Cholecalciferol (Vit D3) 7000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01092338
NCT01092338Phase 2Completed
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Safe and Effective Vitamin D Supplementation in HIV

Children's Hospital of Philadelphia·interventional·Posted Mar 24, 2010·Updated Sep 18, 2013

In Brief

A Phase 2 clinical trial evaluating Cholecalciferol (Vit D3) for HIV Infections and AIDS. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, AIDS
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2010
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.3 years ago

Interventions

Cholecalciferol (Vit D3)drug

To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.