Vitamin D Supplementation in HIV

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Virginia Stallings, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01475890
First received: September 13, 2011
Last updated: July 7, 2014
Last verified: July 2014

September 13, 2011
July 7, 2014
July 2011
June 2013   (final data collection date for primary outcome measure)
Vitamin D Supplementation Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)
Vitamin D Supplementation Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Vit D3 and serum calcium will be measured at each protocol which to determine if Vit D3 supplementation is safe and does not result in an increased incidence of elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL) in treated subjects compared with the subjects receiving placebo.
Complete list of historical versions of study NCT01475890 on ClinicalTrials.gov Archive Site
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Vitamin D Supplementation in HIV
Safe and Effective Vitamin D Supplementation in HIV

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV-infection/Aids
  • Dietary Supplement: Vitamin D3
    7000IU per day of vitamin D3 for 12 months.
  • Dietary Supplement: Placebo
    Once a day for 12 months.
  • Active Comparator: 7000IU/day
    29 subjects will be randomized to receive 7000IU/day of vitamin D3.
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Placebo
    29 subjects will be randomized to receive placebo.
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
58
August 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01475890
11_008093, 5R01AT005531-02
No
Virginia Stallings, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
  • National Institutes of Health (NIH)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Virginia A Stallings, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP