Phase 3 N=190 Randomized Quadruple-blind Treatment

Vitamin D Supplementation in HIV Youth

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT01523496 ↗

Enrolled (actual)

190

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Changes in Serum 25(OH)D3 Levels — 11; 22; 7.5; 25 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vitamin D control dose (Drug); Vitamin D supplementation- (Drug)
Age: Pediatric, Adult · 8+ yrs
Sex: All
Sponsor: University Hospitals Cleveland Medical Center
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Serum 25(OH)D3 Levels	11; 22; 7.5; 25	—
SECONDARY Changes in Vitamin D Binding Protein (VDBP)	3.9; -8.9; -11.3; -11.7	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Ages 8-25
Documented HIV-1 infection
On stable antiretroviral therapy for > 3 months
Cumulative antiretroviral therapy of at least 6 months
25(OH)D level 400 IU daily regular vitamin D intake
Parathyroid/calcium disorders
Active malignancy
Pregnancy/intent to become pregnant/breastfeeding
Chronic infectious/inflammatory conditions
Creatinine clearance 2.5 upper limit of normal
Diabetes requiring hypoglycemic agents
Known coronary artery disease
Inability to swallow pills

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01523496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.