Roles of Vitamin D and HDL in Obese Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Roles of Vitamin D and HDL in Obese Children

Conditions
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Obese, Vitamin D Deficiency, Low HDL

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese children Vitamin D deficiency Low HDL Exclusion Criteria: HIV Hepatitis A Hepatitis B Hepatitis C Non-English speaking

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viatamin D<br>All children enrolled into the study will be prescribed standard of care vitamin D. | Dietary Supplement: Vitamin D<br>* All subjects enrolled into the study will be prescribed standard of care Vitamin D<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Children, Vitamin D deficiency, Low HDL