Vitamin D Supplementation in HIV Youth

This study has been completed.

Sponsor:

Collaborator:

Emory University

Information provided by (Responsible Party):

Grace McComsey, University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT01523496

First received: January 27, 2012

Last updated: February 9, 2017

Last verified: February 2017

History of Changes

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: 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:

MedlinePlus related topics: HIV/AIDS Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

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


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

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
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):

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.


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
Study First Received:	January 27, 2012
Last Updated:	February 9, 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

ClinicalTrials.gov processed this record on June 23, 2017

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