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Vitamin D Supplementation in HIV Youth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523496
First Posted: February 1, 2012
Last Update Posted: December 11, 2017
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.
Collaborator:
Emory University
Information provided by (Responsible Party):
Grace McComsey, University Hospitals Cleveland Medical Center
January 27, 2012
February 1, 2012
December 11, 2017
December 2011
August 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01523496 on ClinicalTrials.gov Archive Site
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 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.
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.
Not Provided
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 D3
    Vitamin D3, randomized to receive either 18,000 IU per month, 60,000 IU per month or 120,000 IU per month
  • Drug: Vitamin D3
    Vitamin D3 18,000IU/month; 60,000IU/month; 120,000IU/month
  • Active Comparator: HIV + Young Adults
    All will be HIV+ and receiving randomized dose of vitamin D3
    Interventions:
    • Drug: Vitamin D3
    • Drug: Vitamin D3
  • Active Comparator: HIV - Controls
    HIV negative controls randomized to one of 3 doses of Vitamin D3
    Interventions:
    • Drug: Vitamin D3
    • Drug: Vitamin D3
Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016 May;11(3):277-84. doi: 10.1097/COH.0000000000000272. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
295
August 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 8-25
  • Documented HIV-1 infection
  • On stable ART for > 3 months
  • Cumulative ART 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
  • AST and ALT > 2.5 ULN
  • 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 2017

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