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OpenTrials
Completed

NCT Number: NCT01410305

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

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

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory Chldren's Center, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Vitamin D levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Emory-Children's Center

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2011
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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