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Vitamin D Supplementation in HIV

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status and phase

Completed
Phase 3
Phase 2

Conditions

HIV-infection/Aids

Treatments

Dietary Supplement: Vitamin D3
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01475890
5R01AT005531-02 (U.S. NIH Grant/Contract)
11-008093

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

5 to 24 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

58 participants in 2 patient groups, including a placebo group

7000IU/day
Active Comparator group
Description:
29 subjects will be randomized to receive 7000IU/day of vitamin D3.
Treatment:
Dietary Supplement: Vitamin D3
Placebo
Placebo Comparator group
Description:
29 subjects will be randomized to receive placebo.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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