Vitamin D Supplementation in HIV Youth

This study is currently recruiting participants.
Verified February 2013 by University Hospitals of Cleveland
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01523496
First received: January 27, 2012
Last updated: January 29, 2014
Last verified: February 2013

January 27, 2012
January 29, 2014
December 2011
December 2015   (final data collection date for primary outcome measure)
Vitamin D levels [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV+
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
October 2016
December 2015   (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
Both
8 Years to 25 Years
Yes
Not Provided
United States
 
NCT01523496
09-11-06
Yes
Grace McComsey, University Hospitals of Cleveland
University Hospitals of Cleveland
Emory University
Principal Investigator: Grace McComsey, MD, FIDSA University Hospital Case Medical Center
University Hospitals of Cleveland
February 2013

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