Roles of Vitamin D and HDL in Obese Children
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Other Indications, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 5 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | January 2016 |
| End Date: | June 2018 |
| Contact: | Xiang An-Li, PhD |
| Email: | Xli2@uky.edu |
| Phone: | (859) 257-5113 |
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.
children and low high density lipoprotein (HDL) and dysfunctional HDL.
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.
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.
Inclusion Criteria:
- Obese children
- Vitamin D deficiency
- Low HDL
Exclusion Criteria:
- HIV
- Hepatitis A
- Hepatitis B
- Hepatitis C
- Non-English speaking
We found this trial at
1
site
Lexington, Kentucky 40536
Principal Investigator: Xiang An-Li, PhD
Phone: 859-323-6426
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