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

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Metabolism Inflammation, and Cardiovascular Risk in HIV-infected Children and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410305
• Other study ID #: 1Ro1HD070490-01
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: June 24, 2016
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2016
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 25 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	Emory Chldren's Center	Atlanta	Georgia
United States	University Hospitals Case Medical Center, Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Emory-Children's Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D levels	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.	One time point at entry	No