Evaluation of Calcium and Vitamin D Supplementation for Optimizing Bone Health During Marine Corps Recruit Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Serum Bone Health Biomarkers (Composite)
研究概览
简要总结
The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength in Marine Corps recruits. The investigators hypothesize that Ca+D will prevent elevations in PTH and result in greater increases in indices of bone strength compared to placebo.
详细描述
Military recruits undergoing initial military training (IMT) are 17 times more likely to develop stress fractures compared to active duty service members. Up to 800 male and female recruits will be enrolled at the MCRD, Parris Island, SC over two seasons (summer/fall and winter/spring) in order to account for seasonal variation in vitamin D status. Ca (2000 mg/d) and vitamin D (1000 IU/d) will be supplied as either capsules or a fortified food product daily throughout training. This study will provide novel data for the military, medical and scientific communities regarding the relationship between Ca and vitamin D supplementation and biomarkers of immune function, and the requirements for calcium and vitamin D to support bone health during IMT.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Marine Corps recruit at least 17 years of age.
排除标准
- •Pregnant or breastfeeding
- •History of kidney stones or kidney disease
- •History of endocrine disorders
- •Allergies to any component of the food product bar
结局指标
主要结局
Serum Bone Health Biomarkers (Composite)
时间窗: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Effect of calcium/vitamin D on the following serum biomarkers: 25(OH)D (ng/ml), parathyroid hormone (PTH) (pg/ml), C-telopeptide cross-links of type 1 collagen (CTX) (ng/ml), tartrate-resistant acid phosphatase (TRAP) (U/L), bone alkaline phosphatase (BAP) (ug/L), procollagen I N-terminal peptide (P1NP) (ug/L)
次要结局
- Bone Strength Indices (Composite)(Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks)