Status:
COMPLETED
Vitamin D Supplementation in HIV
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
HIV-infection/Aids
Eligibility:
All Genders
5-24 years
Phase:
PHASE2
PHASE3
Brief 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 synd...
Detailed 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 im...
Eligibility Criteria
Inclusion
- HIV seropositive diagnosed with standard techniques
- Age for PA Group: 5.0 to 24.9 y
- Age for BA Group: 15.0 to 24.9 y
- In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment)
- Subject and/or family commitment to the 12-month study
Exclusion
- Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status
- Pregnancy
- Participation in another HIV intervention study with impact on 25D serum concentrations
- Use of vit D3 supplementation for the purpose of treating vit D deficiency
- 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)
- Non-English Speaking
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01475890
Start Date
July 1 2011
End Date
February 1 2017
Last Update
March 17 2017
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104