Vitamin D Dose Finding Study

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. HIV seropositive diagnosed with standard techniques

2. Age for perinatally-acquired HIV/AIDS Group (PA subjects): 5.0 to 24.9 y

3. Age for non-perinatally-acquired HIV/AIDS Group (non-PA subjects): 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)

5. Subject and/or family commitment to the 3-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 D supplementation (subjects willing to discontinue supplementation will become eligible after a 2-month washout period)

5. Baseline elevated serum calcium concentration

6. Non-English speaking