Phase 2
N=44
Vitamin D Dose Finding Study
HIV Infections · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT01092338 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Safety — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cholecalciferol (Vit D3) (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety |
0; 0 | — |
| PRIMARY Efficacy of the Two Doses (4000 and 7000 IU/d) |
16; 19 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01092338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.