Optimizing Vitamin D Status During Initial Military Training: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 342
- 试验地点
- 4
- 主要终点
- Serum PTH pg/ml
研究概览
简要总结
The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the effect of vitamin D and calcium supplementation (800IU and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during Army basic combat training (BCT) and Air Force basic military training (BMT).
The investigators hypothesize that daily supplementation with vitamin D and calcium during military training will improve vitamin D status, stabilize PTH levels, and result in improvements in markers of bone health. As a result of the investigators study design, the findings will provide critically important data regarding the concentration of vitamin D in blood necessary to stabilize PTH levels and to optimize bone formation during initial military training.
详细描述
Vitamin D is an essential nutrient for maintaining bone health. Previous work from our laboratory indicates that vitamin D status may decline in Soldiers during BCT, even during the summer months in the Southeastern United States. Stress fractures may affect up to 5% of male and 21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel, but a recent report indicates that vitamin D and calcium supplementation may attenuate stress fracture risk by up to 20% in female Navy recruits. However, biochemical measures of nutritional status and associated markers of bone health were not collected in that study, leaving questions regarding the vitamin D and calcium requirements for military personnel during periods of elevated bone turnover.
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
- 17 Years 至 42 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male US Army or US Air Force Recruits
- •Participating in Basic Combat Training or Basic Military Training, respectively
排除标准
- •Pregnant or breastfeeding
- •History of kidney stones or kidney disease
研究组 & 干预措施
Ca/Vit D
干预措施: Ca/Vit D (Dietary Supplement)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Serum PTH pg/ml
时间窗: Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 weeks
次要结局
未报告次要终点