Trial record 18 of 21 for:    " December 28, 2011":" January 27, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.


Condition Intervention Phase
HIV+
Drug: Vitamin D3
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation and HIV-related Complications in Children and Young Adults

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 180
Study Start Date: December 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HIV + Young Adults
All will be HIV+ and receiving randomized dose of vitamin D3
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 - Controls
HIV negative controls randomized to one of 3 doses of Vitamin D3
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

  Eligibility

Ages Eligible for Study:   8 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523496

Locations
United States, Georgia
Emory Children's Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Allison r Eckard, MD    404-727-8224    allison.ross.eckard@emory.edu   
Principal Investigator: Allison R. Eckard, MD         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Norma Storer, RN    216-844-2752    storer.norma@clevelandactu.org   
Contact: Danielle Labbato, RN    216-844-2739    danielle.labbato@uhhospitals.org   
Principal Investigator: Grace McComsey, MD         
Sponsors and Collaborators
University Hospitals of Cleveland
Emory University
Investigators
Principal Investigator: Grace McComsey, MD, FIDSA University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Grace McComsey, Professor of Pediatrics and Medicine, Chief Pediatric Infectious Diseases, Rheumatology and Global Health, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01523496     History of Changes
Other Study ID Numbers: 09-11-06
Study First Received: January 27, 2012
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
HIV+
Vitamin D Deficiency

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014