Vitamin D Dose Finding Study
Completed · Phase 2
Conditions studied: HIV Infections, AIDS
In brief
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.
Key facts
- Study ID
- NCT01092338
- Run by
- Children's Hospital of Philadelphia
- People needed
- 44
- Starts
- 2010-01-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2013-09-18
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 perinatally-acquired HIV/AIDS Group (PA subjects): 5.0 to 24.9 y
- Age for non-perinatally-acquired HIV/AIDS Group (non-PA subjects): 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)
- Subject and/or family commitment to the 3-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 D supplementation (subjects willing to discontinue supplementation will become eligible after a 2-month washout period)
- Baseline elevated serum calcium concentration
- 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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