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: February 8, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2012

Last Updated Date

February 8, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01523496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vitamin D Supplementation in HIV Youth

Official Title ^ICMJE

Vitamin D Supplementation and HIV-related Complications in Children and Young Adults

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

HIV+

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

October 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 25 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01523496

Other Study ID Numbers ^ICMJE

09-11-06

Has Data Monitoring Committee

Yes

Responsible Party

Grace McComsey, University Hospitals of Cleveland

Study Sponsor ^ICMJE

University Hospitals of Cleveland

Collaborators ^ICMJE

Emory University

Investigators ^ICMJE

Principal Investigator:

Grace McComsey, MD, FIDSA

University Hospital Case Medical Center

Information Provided By

University Hospitals of Cleveland

Verification Date

February 2013

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

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