This trial is active, not recruiting.

Condition hiv-infection/aids
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
29 subjects will be randomized to receive 7000IU/day of vitamin D3.
vitamin d3
7000IU per day of vitamin D3 for 12 months.
(Placebo Comparator)
29 subjects will be randomized to receive placebo.
Once a day for 12 months.

Primary Outcomes

Vitamin D Supplementation Safety
time frame: 12 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.