Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults

Completed

• Conditions: Vitamin D Deficiency

• Registration Number: NCT01410305
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

The relationship of Vitamin D levels in children and young adults to atherosclerosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Study Start: 2011-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-24
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Exclusion Criteria

• Taking > 800 IU of Vitamin D per day
• Parathyroid or Calcium disorders
• Acute illness and active inflammatory condition
• Chronic illnesses that include malignancy, diabetes, CAD
• Pregnancy and lactation
• Creatinine Clearance <50 ml/min
• Hgb < 9.0 g/dL
• AST and ALT > 2.5 upper limits of normal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitamin D levels	One time point at entry	To perform a cross-sectional analysis of blood vitamin D status among the HIV-infected children and young adults to evaluated the point prevalence fo plasma 25(OH)D levels indicating vitamin D insufficiency, deficiency and severe deficiency, and to compare the prevalence to a matched uninfected healthy control group.

Trial Locations

Locations (2)

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

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