Vitamin D Supplementation in HIV

Children's Hospital of Philadelphia58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HIV-infection/Aids

Interventions

Vitamin D3DIETARY_SUPPLEMENT

7000IU per day of vitamin D3 for 12 months.

PlaceboDIETARY_SUPPLEMENT

Once a day for 12 months.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 24 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Vitamin D Supplementation Safety

elevated serum calcium (above age-specific range) associated with elevated serum 25D (\>160 ng/mL)

Time frame: 12 months

Data from ClinicalTrials.gov

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