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

University Hospitals (UH)

Status: Completed

Conditions: Vitamin D Deficiency

Study type: Observational

Funder types: Other

Identifiers

NCT01410305

1R01HD070490-01

Details and patient eligibility

About

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

Enrollment: 290 patients

Sex: All

Ages: 8 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Documentation of HIV Infection Between ages of 8 and 25

• On stable ART for at least 12 weeks for the HIV+ patients
• Cumulative duration of ART for at least 48 weeks for HIV + patients
• Healthy child/young adult with age and race matched to HIV+ patient for the HIV- controls
• Absence of HIV based on medical and medication history

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

Trial design

290 participants in 2 patient groups

HIV+

Description:

HIV Positive children or young people between the ages of 8 and 25

HIV Negative

Description:

HIV Negative matched controls by age and race