The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Bone mineral content
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Bone mineral content
时间窗: Baseline
次要结局
未报告次要终点
研究者
Benjamin U. Nwosu
Study Principal Investigator
University of Massachusetts, Worcester