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. (see Contacts and Locations)
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: July 2, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Emory Children's Center Active, not recruiting
Atlanta, Georgia, United States, 30322
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: July 2, 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 July 24, 2014