Roles of Vitamin D and HDL in Obese Children | NCT02135913

Studies
Roles of Vitamin D and HDL in Obese Children

NCT02135913

Sponsor

Xiang-An Li

Status

Completed

Last Update Posted

May 2, 2017Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Obese
Vitamin D Deficiency
Low HDL

Interventions

Vitamin D

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Apr 26, 2017Actual

Completion Date

Apr 26, 2017Actual

First Submitted Date

Apr 25, 2014

First Submission Date that Met QC Criteria

May 6, 2014

First Posted Date

May 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2017

Last Update Posted Date

May 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiang-An Li, Principal Investigator, University of KentuckySponsor-Investigator

Lead Sponsor

Xiang-An LiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Viatamin D	Experimental	All children enrolled into the study will be prescribed standard of care vitamin D.	Dietary Supplement: Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Dietary Supplement	All subjects enrolled into the study will be prescribed standard of care Vitamin D	Viatamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obese children
Vitamin D deficiency
Low HDL

Exclusion Criteria:

HIV
Hepatitis A
Hepatitis B
Hepatitis C
Non-English speaking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiang An-Li, PhD	University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky Chandler Medical Center		Lexington	Kentucky	40536	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided