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Vitamin D Dose Finding Study

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01092338
First received: March 23, 2010
Last updated: August 1, 2013
Last verified: August 2013

March 23, 2010
August 1, 2013
January 2010
January 2011   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml).
  • Efficacy of the Two Doses (4000 and 7000 IU/d) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Daily D3 supplementation will result in 25D >= to 32/ng/ml
Safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status determined by achieving a minimum serum 25D concentration of 32 ng/mL. [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01092338 on ClinicalTrials.gov Archive Site
Not Provided
Cathelicidin antimicrobial protein activity will be used as an indicator of immune response to vit D depletion and repletion. [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vitamin D Dose Finding Study
Safe and Effective Vitamin D Supplementation in HIV

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 key role of vitamin D (vit D) in maintaining optimal bone health has long been recognized, but its role in modulating the innate immune response and inflammatory reaction has only recently come under active investigation. As such, vit D is an increasingly frequently chosen and prescribed high dose dietary supplement,because it is thought to improve immune and inflammatory status in healthy people of all ages, and in those with chronic diseases including HIV/AIDS. Vit D also has calciotrophic functions essential for bone health, and poor vit D status contributes to the osteopenia/osteoporosis associated with antiretroviral therapy (ART). Vit D may improve insulin/glucose/lipid metabolism, blood pressure and risk of some cancers, all of which may complicate HIV/AIDS and its treatments. Poor vit D status is common in patients with HIV/AIDS of all ages and factors such as age, skin pigment, lactose intolerance and sun exposure alter the risks for vit D deficiency. In the multicenter U.S. REACH study of adolescents (72% African American), with and without HIV, showed that 87% had low serum 25D concentrations (<15 ng/mL), compared to 34% in a recent sample of healthy African American children from Philadelphia. Young African Americans are disproportionately affected by HIV infection in the US (~ 55% among persons with HIV aged 13 to 24 years are African American), and are also at high risk for vit D deficiency. Vit D therapy has great promise to improve major medical conditions and the quality of life for our patients with HIV/AIDS, yet the potential role of vit D in the treatment of HIV/AIDS has not been formally tested. Well-designed randomized trials are urgently needed to determine vit D supplementation safety and efficacy.

The investigators propose a two-phase study to establish safety and efficacy of high dose vit D supplementation in children and adults with HIV/AIDS. In Study Phase I, the safety and efficacy of two oral vit D3 doses (4000 and 7000 IU/d) are determined over 12 weeks in 44 subjects ages 5.0 to 24.9 y. The key safety measure is concurrently elevated serum calcium and 25D concentrations. Efficacy is evaluated by serum 25D concentration and cathelicidin (innate immune, antimicrobial protein) mRNA expression. Study Phase II is a 12 month, double blind, randomized, placebo controlled supplementation study (n=52). Key outcomes include safety and longterm 25D concentration within the goal range (32 to 160 ng/mL), improved cathelicidin mRNA expression, and measures of bone, muscle, inflammation, growth and body composition status, and HIV/AIDS disease severity. Based on the evidence and promise, vit D clearly deserves to be among the first nutrients evaluated in the National Center for Complimentary and Alternative Medicine (NCCAM) HIV research program.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
Drug: Cholecalciferol (Vit D3)
To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.
Other Names:
  • Carlson D Drops: The D Drop Company
  • Nutraceutical Life Sciences Vitamin D3 2000 IU capsules: Vitacost
  • NOW Foods 5000 IU softgels: Now Health Group, Inc.
  • Active Comparator: 4000IU
    Subjects in this arm take a daily dose of 4000IU of Vitamin D3
    Intervention: Drug: Cholecalciferol (Vit D3)
  • Active Comparator: 7000IU
    Subjects in this arm of the study take a daily dose of 7000IU of Vitamin D3
    Intervention: Drug: Cholecalciferol (Vit D3)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01092338
09-007332, R01AT005531
Yes
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 Stallings, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
August 2013

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