Low HDL, Obese, Vitamin D Deficiency
Conditions
Keywords
Obese, Children, Vitamin D deficiency, Low HDL
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
All subjects enrolled into the study will be prescribed standard of care Vitamin D
Sponsors
Xiang-An Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Obese children * Vitamin D deficiency * Low HDL
Exclusion criteria
* HIV * Hepatitis A * Hepatitis B * Hepatitis C * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation | up to 24 months | Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation | up to 24 months | Supplementation of Vitamin D to obese children with low Vitamin D/low HDL corrects Vitamin D deficiency, restores HDL levels and functions. |
Countries
United States
Outcome results
None listed