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OpenTrials
Completed

NCT Number: NCT02135913

Roles of Vitamin D and HDL in Obese Children

This is a pilot study to determine the association between Vitamin D deficiency in obese children and low high density lipoprotein (HDL) and dysfunctional HDL.

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Key information

Conditions

Obese Avitaminosis Body Weight Deficiency Diseases Low HDL Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin D Deficiency

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

About this study

Subjects will be identified through the Department of Pediatric - High Body Mass Index (BMI) Clinic by Dr. Aurelia Radulescu during standard of care visit. Dr. Radulescu will determine if the subject meets study eligibility requirements.

Visit 1 (Baseline/Screening): Consent/assent will be obtained, medical history, demographic information along with height and weight will be collection. Clinical Laboratory testing, although not part of this study, will include the following standard of care tests. The results of Vitamin D and Lipid profile testing will be shared with Dr. Li by Dr. Radulescu.

  • Lipid profile
  • Vitamin D
  • AST/ALT
  • Hb A1C
  • Glucose
  • CBS w/diff
  • TSH
  • BUN, Creatine
  • UA

Subjects will be placed on standard of care Vitamin D supplementation for 12 weeks.

Visit 2 (3 month visit) End of Study: Subjects will return to the BMI clinic at month 3 for follow-up and additional clinical laboratory testing (see visit 1 for a description of testing to be performed) in order to assess their response to Vitamin D supplementation. Subjects with previously reported abnormal Lipid values will have a Lipid profile repeated at this visit. Month 3 visit will be the End of Study visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Obese children
  • Vitamin D deficiency
  • Low HDL

Exclusion criteria

  • HIV
  • Hepatitis A
  • Hepatitis B
  • Hepatitis C
  • Non-English speaking

Treatment and study plan

Vitamin D

Dietary Supplement

All subjects enrolled into the study will be prescribed standard of care Vitamin D

Primary outcomes

  1. Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation

    Time frame: up to 24 months

    Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL

Secondary outcomes

  1. Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation

    Time frame: up to 24 months

    Supplementation of Vitamin D to obese children with low Vitamin D/low HDL corrects Vitamin D deficiency, restores HDL levels and functions.

Sponsors and collaborators

Lead sponsor

Xiang-An Li

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 12, 2014
Registry last updated
May 2, 2017

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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