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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: February 10, 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
  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 Infections Drug: Vitamin D3 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Grace McComsey, University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 295
Study Start Date: December 2011
Study Completion Date: August 2016
Primary Completion Date: August 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523496


Locations
United States, Georgia
Emory Children's Center
Atlanta, Georgia, United States, 30322
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Emory University
Investigators
Principal Investigator: Grace McComsey, MD, FIDSA University Hospitals Cleveland Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Grace McComsey, Professor of Pediatrics and Medicine, Chief Pediatric Infectious Diseases, Rheumatology and Global Health, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01523496     History of Changes
Other Study ID Numbers: 09-11-06
First Submitted: January 27, 2012
First Posted: February 1, 2012
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Grace McComsey, University Hospitals Cleveland Medical Center:
HIV
Vitamin D Deficiency

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents