drugset / Trial / NCT01092338
Vitamin D Dose Finding Study
Phase 2
Completed
44 enrolled
Children's Hospital of Philadelphia
National Center for Complementary and Integrative Health (NCCIH) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2010-01
- Primary completion
- 2011-01
- Completion
- 2011-01
Publications
- Results Groleau V, Herold RA, Schall JI, Wagner JL, Dougherty KA, Zemel BS, Rutstein RM, Stallings VA. Blood lead concentration is not altered by high-dose vitamin D supplementation in children and young adults with HIV. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):316-9. doi: 10.1097/MPG.0b013e3182758c4a.
- Dougherty KA, Schall JI, Zemel BS, Tuluc F, Hou X, Rutstein RM, Stallings VA. Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus. J Pediatric Infect Dis Soc. 2014 Dec;3(4):294-303. doi: 10.1093/jpids/piu012. Epub 2014 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cholecalciferol | Other / unclassified | 4000 iu | Oral |
| Comparator | Cholecalciferol | Other / unclassified | 7000 iu | Oral |