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

NCT01410305 | Completed

• 1 other identifier: 1R01HD070490-01
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Vitamin D Deficiency

Keywords

Vitamin D Deficiency; HIV+ Children; HIV+ Young Adults

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HIV+

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

HIV Negative

HIV Negative matched controls by age and race

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Any HIV+ patient between the ages of 8 and 25 and matched HIV- controls matched by age and race.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Emory-Children's Center: collaborator

Study Sites (2)

Emory Chldren's Center

Atlanta, Georgia, 30308, United States

Location

University Hospitals Case Medical Center, Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, PBMCs, urine

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Grace McComsey, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Allison Ross Eckard, MD

  Emory-Children's Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Medicine

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 5, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

US (2)