Roles of Vitamin D and HDL in Obese Children

Not Applicable

Completed

• Conditions: Obese; Vitamin D Deficiency; Low HDL
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT02135913
• Lead Sponsor: Xiang-An Li

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-12
• Study Start: 2016-01-01
• Status Verified: 2017-04
• Primary Completion: 2017-04-26
• Study Completion: 2017-04-26
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Obese children
• Vitamin D deficiency
• Low HDL

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viatamin D	Vitamin D	All children enrolled into the study will be prescribed standard of care vitamin D.

Primary Outcome Measures

Name	Time	Method
Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation	up to 24 months	Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL

Secondary Outcome Measures

Name	Time	Method
Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation	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.

Trial Locations

Locations (1)

University of Kentucky Chandler Medical Center; 🇺🇸 Lexington, Kentucky, United States