Roles of Vitamin D and HDL in Obese Children

Xiang-An Li1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Obese Vitamin D Deficiency Low HDL

Interventions

Vitamin DDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Obese children * Vitamin D deficiency * Low HDL Exclusion Criteria: * HIV * Hepatitis A * Hepatitis B * Hepatitis C * Non-English speaking

Locations (1)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation

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

Time frame: up to 24 months

Secondary Outcomes

Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation

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

Time frame: up to 24 months

Data from ClinicalTrials.gov

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