Vitamin D Supplementation in HIV Youth

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Vitamin D control dose; Drug: Vitamin D supplementation-

• Registration Number: NCT01523496
• Lead Sponsor: University Hospitals Cleveland Medical Center

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

The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2017-10-24
• Results First Submitted QC: 2018-01-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Results First Posted: 2018-02-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 < 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
• Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal
• Diabetes requiring hypoglycemic agents
• Known coronary artery disease
• Inability to swallow pills

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV - Controls	Vitamin D control dose	HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
HIV + Young Adults	Vitamin D supplementation-	All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
HIV - Controls	Vitamin D supplementation-	HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
HIV + Young Adults	Vitamin D control dose	All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)

Primary Outcome Measures

Name	Time	Method
Changes in Serum 25(OH)D3 Levels	6 months	Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )

Secondary Outcome Measures

Name	Time	Method
Changes in Vitamin D Binding Protein (VDBP)	6 months	Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.

Trial Locations

Locations (2)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Emory Children's Center; 🇺🇸 Atlanta, Georgia, United States