Vitamin D Dose Finding Study
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The key role of vitamin D (vit D) in maintaining optimal bone health has long been
      recognized, but its role in modulating the innate immune response and inflammatory reaction
      has only recently come under active investigation. As such, vit D is an increasingly
      frequently chosen and prescribed high dose dietary supplement,because it is thought to
      improve immune and inflammatory status in healthy people of all ages, and in those with
      chronic diseases including HIV/AIDS. Vit D also has calciotrophic functions essential for
      bone health, and poor vit D status contributes to the osteopenia/osteoporosis associated with
      antiretroviral therapy (ART). Vit D may improve insulin/glucose/lipid metabolism, blood
      pressure and risk of some cancers, all of which may complicate HIV/AIDS and its treatments.
      Poor vit D status is common in patients with HIV/AIDS of all ages and factors such as age,
      skin pigment, lactose intolerance and sun exposure alter the risks for vit D deficiency. In
      the multicenter U.S. REACH study of adolescents (72% African American), with and without HIV,
      showed that 87% had low serum 25D concentrations (<15 ng/mL), compared to 34% in a recent
      sample of healthy African American children from Philadelphia. Young African Americans are
      disproportionately affected by HIV infection in the US (~ 55% among persons with HIV aged 13
      to 24 years are African American), and are also at high risk for vit D deficiency. Vit D
      therapy has great promise to improve major medical conditions and the quality of life for our
      patients with HIV/AIDS, yet the potential role of vit D in the treatment of HIV/AIDS has not
      been formally tested. Well-designed randomized trials are urgently needed to determine vit D
      supplementation safety and efficacy.

      The investigators propose a two-phase study to establish safety and efficacy of high dose vit
      D supplementation in children and adults with HIV/AIDS. In Study Phase I, the safety and
      efficacy of two oral vit D3 doses (4000 and 7000 IU/d) are determined over 12 weeks in 44
      subjects ages 5.0 to 24.9 y. The key safety measure is concurrently elevated serum calcium
      and 25D concentrations. Efficacy is evaluated by serum 25D concentration and cathelicidin
      (innate immune, antimicrobial protein) mRNA expression. Study Phase II is a 12 month, double
      blind, randomized, placebo controlled supplementation study (n=52). Key outcomes include
      safety and longterm 25D concentration within the goal range (32 to 160 ng/mL), improved
      cathelicidin mRNA expression, and measures of bone, muscle, inflammation, growth and body
      composition status, and HIV/AIDS disease severity. Based on the evidence and promise, vit D
      clearly deserves to be among the first nutrients evaluated in the National Center for
      Complimentary and Alternative Medicine (NCCAM) HIV research program.
    

Intervention name(s): Cholecalciferol (Vit D3)
Intervention type(s): Drug
Intervention description(s): To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.
Other intervention name(s): Carlson D Drops: The D Drop Company; Nutraceutical Life Sciences Vitamin D3 2000 IU capsules: Vitacost; NOW Foods 5000 IU softgels: Now Health Group, Inc.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome; Vitamin D; HIV; Complementary therapies