Vitamin D Status and Dose Response in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Serum 25-Hydroxyvitamin D [25(OH)D] Levels
研究概览
简要总结
This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.
详细描述
It is hypothesized that serum 25(OH)D levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/Ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Minutes 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •greater than 32 weeks gestation,
- •exclusively formula fed.
排除标准
- •less than 32 weeks gestation,
- •less than 1500 grams,
- •recieving maternal breast milk,
- •recieving parenteral nutrition,
- •congenital anomolies,
- •disorders of vitamin D metabolism,
- •inborn errors of metabolism,
- •seizure disorders,
- •parathroid disease,
- •liver, GI tract, or kidney disease, and
- •disorders of calcium metabolism.
结局指标
主要结局
Serum 25-Hydroxyvitamin D [25(OH)D] Levels
时间窗: 30 days
Total serum 25(OH)D level is currently considered the best indicator of vitamin D supply to the body from cutaneous synthesis and nutritional intake. For infants, ≤37.5 nmol/L (15 ng/mL) would be considered indicative of deficiency and \>50 nmol/L (20 ng/mL) as indicative of vitamin D sufficiency.
次要结局
- Serum C-reactive protein (CRP)(30 days)
- Serum intact parathyroid hormone (iPTH)(30 days)