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
About this trial
This is an interventional diagnostic trial for Obese focused on measuring Obese, Children, Vitamin D deficiency, Low HDL
Eligibility Criteria
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
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
Learn more about this trial
Roles of Vitamin D and HDL in Obese Children
We'll reach out to this number within 24 hrs