Vitamin D Supplementation in HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV-infection/Aids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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7000IU/day

29 subjects will be randomized to receive 7000IU/day of vitamin D3.

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

7000IU per day of vitamin D3 for 12 months.

Placebo

29 subjects will be randomized to receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Once a day for 12 months.

Interventions

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Vitamin D3

7000IU per day of vitamin D3 for 12 months.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Once a day for 12 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No