Vitamin D Concentrations and Their Effect on Glucose Metabolism in Pediatrics
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance.
研究概览
简要总结
The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates that the physiologic functions of vitamin D are much broader than its well-known role in the regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type I diabetes. Recent epidemiological evidence points to a strong association between vitamin D insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The investigators would like to examine the role of vitamin D in the development of insulin resistance in overweight children and adolescents, which represent a high risk population for cardiovascular and metabolic complications. The investigators propose a prospective randomized clinical trial of vitamin D supplementation in overweight, insulin resistant, vitamin D deficient children. The investigators objective is to assess if changes in insulin resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these patients post treatment with vitamin D. Additionally, concomitant changes in calcium and bone metabolism after vitamin D treatment will be evaluated. This is because, contrary to adults, the optimal vitamin D concentrations that regulate calcium and bone metabolism have not been established in pediatrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI>85th% for age & sex
- •Vitamin D25 between 10-20ng/ml
- •Normal serum Ca concentrations >8.5mg/dl
- •Evidence of insulin resistance (measured by HOMA-IR, and QUICKI indices)
排除标准
- •Vitamin D25<10ng/ml
- •No parental consent
- •No evidence of insulin resistance
- •BMI < 85th percentile
- •Known diagnosis of type 1 or 2 diabetes
- •Severe underlying disease such as liver disease, end-stage renal disease, or malignancy
- •Present medication that affects insulin sensitivity such as steroids or Metformin
- •Any chronic illness or administration of medications that is associated with fat malabsorption as they may interfere with vitamin D absorption.
- •Known history of hypocalcemia, calcium disorder (such as Di George syndrome)
- •Serum Calcium concentration < 8.5mg/dl
- •Other drugs that might effect vitamin D metabolism due to induction of P450 enzyme activity.
研究组 & 干预措施
Vitamin D
Subjects will randomly be assigned to Vitamin D drops versus placebo drops.
干预措施: Vitamin D drops (Drug)
Placebo
Subjects will randomly be assigned to Vitamin D drops versus placebo drops.
干预措施: Placebo drops (Drug)
结局指标
主要结局
To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance.
时间窗: 4 months
To our knowledge, there are no prospective randomized clinical trials on examining the effects of vitamin D treatment on insulin resistance and bone metabolism in vitamin D deficient, insulin resistant, obese children. We would like to determine if giving Vitamin D supplementation to obese children will help reduce their insulin resistance. We plan to measure Vitamin D levels and HOMA-IR at baseline and compare this to levels post-supplementation. Our timeframe is baseline and 4 months.
次要结局
- To quantify the associations between vitamin D 25 concentration, insulin resistance, and calcium metabolism in overweight children.(4 months)