Vitamin D Supplementation in HIV
Vitamin D Supplementation in HIV
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.
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.
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