Vitamin D Deficiency and Low Bone Mineral Content in Children (VDS)
The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children
The Vitamin D study is designed to investigate the effect of body fat mass on vitamin D levels in children. Earlier studies have shown that individuals with increased fat mass may have low vitamin D levels.
Our specific hypothesis states that children with increased fat mass will have lower blood levels of vitamin D when compared to non-obese children.Since vitamin D is the primary hormone for bone mineralization in humans, low levels of vitamin D could lead to decreased bone mineral content in these children.
研究概览
详细说明
Fifty prepubertal male and female children of ages between 3-12 years will participate in this study. Of these, 25 obese children will be enrolled in the study group, and 25 non-obese children will serve as controls.
All subjects will fill out a comprehensive mineral intake questionnaire as part of the study to ensure adequate calcium intake prior to the study.
All subjects will collect a first morning urine sample for calcium, creatinine, and NTX.
Fasting blood samples will be drawn for the following analytes: 25-hydroxyvitamin D, 1, 25-dihydroxyvitamin D, intact PTH, calcium, phosphorus, magnesium, osteocalcin, insulin, c-peptide, fasting blood glucose, leptin, and adiponectin.
Bone Mineral Content will be evaluated in 16 obese subjects with vitamin D level of < 30 nmol/L.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Worcester、Massachusetts、美国、01655
- University of Massachusetts Medical School
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- General: Prepubertal children (males, with testicular volume of ≤ 3 cc, and girls with Tanner 1 breast) of ages 7-11 years will be enrolled in the study.
- Study group: Subjects with a BMI of > 95th percentile for age and sex.
- Control group: All control subjects will have a BMI of < 85th percentile for age and sex.
Exclusion Criteria:
- known metabolic or genetic diseases resulting in obesity such as severe hypothyroidism, pseudohypoparathyroidism, or Cushing's disease
- diabetes mellitus
- subjects on lipid lowering medications
- subjects on medications known to impact body weight or calcium homeostasis
- subjects with a history of recent significant weight loss or gain
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Obese
Chilren with BMI of >95th percentile
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Non-obese
Children with BMI of <85th percentile
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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骨矿物质含量
大体时间：基线
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基线
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合作者和调查者
调查人员
- 首席研究员：Benjamin U Nwosu, MD、University of Massachusetts, Worcester
- 研究主任：Carol A Cicarrelli, RN、University of Massachusetts, Worcester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.