Vitamin D Supplementation in HIV

HIV-infection/Aids Clinical Trial

Official title:

Safe and Effective Vitamin D Supplementation in HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475890
• Other study ID #: 11-008093
• Secondary ID: 5R01AT005531-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2011
• Last updated: March 15, 2017
• Start date: July 2011
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2017
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• HIV-infection/Aids

Intervention

Dietary Supplement:
• Vitamin D3
7000IU per day of vitamin D3 for 12 months.
• Placebo
Once a day for 12 months.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D Supplementation Safety	elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)	12 months