Roles of Vitamin D and HDL in Obese Children

NCT ID: NCT02135913

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-04-26

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.

Conditions

Obese; Vitamin D Deficiency; Low HDL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Viatamin D

All children enrolled into the study will be prescribed standard of care vitamin D.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Vitamin D

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Obese children
• Vitamin D deficiency
• Low HDL

Exclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiang-An Li

OTHER

Sponsor Role: lead

Responsible Party

Xiang-An Li

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiang An-Li, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

14-0348-P3H

Identifier Type: -

Identifier Source: org_study_id