Roles of Vitamin D and HDL in Obese Children

Xiang-An Li

Status: Completed

Conditions: Low HDL; Obese; Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT02135913

14-0348-P3H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese children
• Vitamin D deficiency
• Low HDL

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Viatamin D

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D