Vitamin D Supplementation in HIV Youth

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523496
• Other study ID #: 09-11-06
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 27, 2012
• Last updated: February 5, 2018
• Start date: December 2011
• Est. completion date: August 2016

Study information

• Verified date: February 2018
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Vitamin D control dose
18,000 IU per month
• Vitamin D supplementation-
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)

Locations

Country	Name	City	State
United States	Emory Children's Center	Atlanta	Georgia
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Serum 25(OH)D3 Levels	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 )	6 months
Secondary	Changes in Vitamin D Binding Protein (VDBP)	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.	6 months