Overview

This trial is active, not recruiting.

Condition hiv+
Treatments vitamin d3
Phase phase 2/phase 3
Sponsor University Hospital Case Medical Center
Collaborator Emory University
Start date December 2011
End date December 2016
Trial size 180 participants
Trial identifier NCT01523496, 09-11-06

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
All will be HIV+ and receiving randomized dose of vitamin D3
vitamin d3
Vitamin D3, randomized to receive either 18,000 IU per month, 60,000 IU per month or 120,000 IU per month
vitamin d3
Vitamin D3 18,000IU/month; 60,000IU/month; 120,000IU/month
(Active Comparator)
HIV negative controls randomized to one of 3 doses of Vitamin D3
vitamin d3
Vitamin D3, randomized to receive either 18,000 IU per month, 60,000 IU per month or 120,000 IU per month
vitamin d3
Vitamin D3 18,000IU/month; 60,000IU/month; 120,000IU/month

Primary Outcomes

Measure
Vitamin D levels
time frame: 24 months

Secondary Outcomes

Measure
Impact of Vitamin D levels on surrogate markers of CVD
time frame: 6, 12 and 24 months

Eligibility Criteria

Male or female participants from 8 years up to 25 years old.

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

Additional Information

Official title Vitamin D Supplementation and HIV-related Complications in Children and Young Adults
Principal investigator Grace McComsey, MD, FIDSA
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University Hospital Case Medical Center.