Vitamin D Supplementation in HIV

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: HIV-infection/Aids

In brief

The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in children, adolescents and young adults with Human Immunodeficiency Virus and acquired immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332.

Key facts

Study ID

NCT01475890

Run by

Children's Hospital of Philadelphia

People needed

58

Starts

2011-07-01

Expected to finish

2017-02-01

Last updated by the study team

2017-03-17

Who can join

Age: 5 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV seropositive diagnosed with standard techniques
• Age for PA Group: 5.0 to 24.9 y
• Age for BA Group: 15.0 to 24.9 y
• In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment)
• Subject and/or family commitment to the 12-month study

You may not qualify if…

• Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status
• Pregnancy
• Participation in another HIV intervention study with impact on 25D serum concentrations
• Use of vit D3 supplementation for the purpose of treating vit D deficiency
• Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period)
• Non-English Speaking

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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