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Vitamin D Supplementation in HIV Youth

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ClinicalTrials.gov Identifier: NCT01523496
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : February 6, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Grace McComsey, University Hospitals Cleveland Medical Center

January 27, 2012
February 1, 2012
October 24, 2017
February 6, 2018
March 8, 2018
December 2011
August 2016   (Final data collection date for primary outcome measure)
Changes in Serum 25(OH)D3 Levels [ Time Frame: 6 months ]
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )
Vitamin D levels [ Time Frame: 24 months ]
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for improving 25(OH)D levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of 3 different dosing regimens of oral Vitamin D supplementation.
Complete list of historical versions of study NCT01523496 on ClinicalTrials.gov Archive Site
Changes in Vitamin D Binding Protein (VDBP) [ Time Frame: 6 months ]
Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.
Impact of Vitamin D levels on surrogate markers of CVD [ Time Frame: 6, 12 and 24 months ]
Evaluate the dose-related efficacy of correction of vitamin D deficiency for improving surrogate markers (Pulse wave velocity, Carotid IMT)of CVD in a group of HIV-infected chidlren and young adults and a matched healthy control group in a randomized controlled study of 3 different dosing regimens of oral vitamin D supplementation.
Not Provided
Not Provided
 
Vitamin D Supplementation in HIV Youth
Vitamin D Supplementation and HIV-related Complications in Children and Young Adults
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: Vitamin D control dose
    18,000 IU per month
    Other Name: 25(OH)D3 low dose
  • Drug: Vitamin D supplementation-
    60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
    Other Name: 25(OH)D3 medium dose or 25(OH)high dose
  • Active Comparator: HIV + Young Adults
    All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
    Interventions:
    • Drug: Vitamin D control dose
    • Drug: Vitamin D supplementation-
  • Active Comparator: HIV - Controls
    HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
    Interventions:
    • Drug: Vitamin D control dose
    • Drug: Vitamin D supplementation-

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
180
August 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 8-25
  • Documented HIV-1 infection
  • On stable antiretroviral therapy for > 3 months
  • Cumulative antiretroviral therapy of at least 6 months
  • 25(OH)D level < 30 ng/ml at screening

Exclusion Criteria:

  • > 400 IU daily regular vitamin D intake
  • Parathyroid/calcium disorders
  • Active malignancy
  • Pregnancy/intent to become pregnant/breastfeeding
  • Chronic infectious/inflammatory conditions
  • Creatinine clearance < 50 ml/min
  • Hemoglobin < 9.0 g/dL
  • Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal
  • Diabetes requiring hypoglycemic agents
  • Known coronary artery disease
  • Inability to swallow pills
Sexes Eligible for Study: All
8 Years to 25 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01523496
09-11-06
Yes
Not Provided
Not Provided
Grace McComsey, University Hospitals Cleveland Medical Center
University Hospitals Cleveland Medical Center
Emory University
Principal Investigator: Grace McComsey, MD, FIDSA University Hospitals Cleveland Medical Center
University Hospitals Cleveland Medical Center
February 2018

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