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Roles of Vitamin D and HDL in Obese Children

Primary Purpose

Obese, Vitamin D Deficiency, Low HDL

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Xiang-An Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obese focused on measuring Obese, Children, Vitamin D deficiency, Low HDL

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obese children
  • Vitamin D deficiency
  • Low HDL

Exclusion Criteria:

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

Sites / Locations

  • University of Kentucky Chandler Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Viatamin D

Arm Description

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

Outcomes

Primary Outcome Measures

Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation
Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2014
Last Updated
April 28, 2017
Sponsor
Xiang-An Li
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1. Study Identification

Unique Protocol Identification Number
NCT02135913
Brief Title
Roles of Vitamin D and HDL in Obese Children
Official Title
Roles of Vitamin D and HDL in Obese Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
April 26, 2017 (Actual)
Study Completion Date
April 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiang-An Li

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Vitamin D Deficiency, Low HDL
Keywords
Obese, Children, Vitamin D deficiency, Low HDL

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Viatamin D
Arm Type
Experimental
Arm Description
All children enrolled into the study will be prescribed standard of care vitamin D.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
All subjects enrolled into the study will be prescribed standard of care Vitamin D
Primary Outcome Measure Information:
Title
Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation
Description
Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obese children Vitamin D deficiency Low HDL Exclusion Criteria: HIV Hepatitis A Hepatitis B Hepatitis C Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang An-Li, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

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Roles of Vitamin D and HDL in Obese Children

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