Vitamin D Supplementation in HIV
This trial is active, not recruiting.
|Treatments||vitamin d3, placebo|
|Phase||phase 2/phase 3|
|Sponsor||Children's Hospital of Philadelphia|
|Collaborator||National Institutes of Health (NIH)|
|Start date||July 2011|
|End date||June 2013|
|Trial size||58 participants|
|Trial identifier||NCT01475890, 11-008093, 5R01AT005531-02|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Vitamin D Supplementation Safety
time frame: 12 months
Male or female participants from 5 years up to 24 years old.
Inclusion Criteria: 1. HIV seropositive diagnosed with standard techniques 2. Age for PA Group: 5.0 to 24.9 y 3. Age for BA Group: 15.0 to 24.9 y 4. In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment) 5. Subject and/or family commitment to the 12-month study Exclusion Criteria: 1. Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status 2. Pregnancy 3. Participation in another HIV intervention study with impact on 25D serum concentrations 4. Use of vit D3 supplementation for the purpose of treating vit D deficiency 5. 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) 6. Non-English Speaking
|Official title||Safe and Effective Vitamin D Supplementation in HIV|
|Principal investigator||Virginia A Stallings, MD|
|Description||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. 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 in 58 subjects with both Perinatally Acquired (PA) and Behaviorally Acquired (BA) HIV/AIDS to assess the long-term safety in terms of serum calcium and 25OHD concentrations, and efficacy in terms of the effect of vit D supplementation on 25OHD, cathelicidin, growth (pre- and peripubertal participants), body composition, bone, muscle, immune and inflammatory status and HIV/AIDS disease severity and progression. Primary Hypotheses: H1: Vit D supplementation is safe and does not result in an increased incidence of elevated serum calcium (above age-specific range) associated with elevated serum 25OHD (>160 ng/mL) in treated subjects compared with the subjects receiving placebo. H2: Vit D supplementation is significantly associated with both increased 25D and cathelicidin in treated subjects compared with subjects receiving placebo.|
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