Vitamin D Supplementation in HIV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01475890|
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV-infection/Aids||Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo||Phase 2 Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safe and Effective Vitamin D Supplementation in HIV|
|Study Start Date :||July 2011|
|Primary Completion Date :||June 2013|
|Study Completion Date :||February 2017|
Active Comparator: 7000IU/day
29 subjects will be randomized to receive 7000IU/day of vitamin D3.
Dietary Supplement: Vitamin D3
7000IU per day of vitamin D3 for 12 months.
Placebo Comparator: Placebo
29 subjects will be randomized to receive placebo.
Dietary Supplement: Placebo
Once a day for 12 months.
- Vitamin D Supplementation Safety [ Time Frame: 12 months ]elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475890
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Virginia A Stallings, MD||Children's Hospital of Philadelphia|