Roles of Vitamin D and HDL in Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese children
- •Vitamin D deficiency
排除标准
- •Hepatitis A
- •Hepatitis B
- •Hepatitis C
- •Non-English speaking
结局指标
主要结局
Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation
时间窗: up to 24 months
Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL
次要结局
- Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation(up to 24 months)
研究者
Xiang-An Li
Principal Investigator
University of Kentucky