Roles of Vitamin D and HDL in Obese Children

Vitamin D Deficiency Clinical Trial

Official title:

Roles of Vitamin D and HDL in Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135913
• Other study ID #: 14-0348-P3H
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: April 28, 2017
• Start date: January 1, 2016
• Est. completion date: April 26, 2017

Study information

• Verified date: April 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 26, 2017
• Est. primary completion date: April 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Obese children

• Vitamin D deficiency

• Low HDL

Exclusion Criteria:

• HIV

• Hepatitis A

• Hepatitis B

• Hepatitis C

• Non-English speaking

Related Conditions & MeSH terms

• Low HDL
• Obese
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
All subjects enrolled into the study will be prescribed standard of care Vitamin D

Locations

Country	Name	City	State
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Xiang-An Li

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation	Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL	up to 24 months
Secondary	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.	up to 24 months