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临床试验/NCT00476346
NCT00476346已完成不适用

Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits

Creighton University2 个研究点 分布在 1 个国家目标入组 5,201 人开始时间: 2002年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,201
试验地点
2
主要终点
individuals with stress fracture

研究概览

简要总结

We conducted a double-blind, placebo-controlled randomized clinical trial of calcium and vitamin D supplementation in 5201 female Naval recruits. During 8 weeks of basic training, supplementation with 2000 mg calcium and 800 IU vitamin D/day decreased incidence of stress fracture by 25%. The hypothesis was:

Supplementation with calcium 2000 mg/d and vitamin D 800 IU/d will significantly reduce the incidence of stress fractures in female Navy recruits during 8 weeks of basic training.

详细描述

Introduction

Stress fractures (SFx) are one of the most common and debilitating overuse injuries seen in military recruits, and they are also problematic for non-military athletic populations. The goal of this randomized double-blind, placebo-controlled study was to determine if a calcium and vitamin D intervention could reduce the incidence of SFx in female recruits during basic training.

Methods: We recruited 5201 female Navy recruit volunteers and randomized them to a 2000 mg calcium and 800 IU vitamin D supplement/day or placebo. SFx were ascertained when recruits reported to the Great Lakes clinic with symptoms. All SFx were confirmed with radiography or technetium scan according to the usual Navy protocol.

Results: A total of 309 subjects were diagnosed with a SFx resulting in an incidence of 5.9% per eight weeks. Using "intention-to-treat" analysis by including all enrolled subjects, Fisher's Exact test found that the calcium and vitamin D group had a 25% lower incidence of SFx than the control group (6.6% vs 5.3%, respectively, p=0.03). The per protocol analysis, including only the 3700 recruits who completed the study, found a 27% lower incidence of fractures in the supplemented vs the control group (8.6% vs 6.8%, respectively, p=0.02).

Conclusions: Generalizing the findings to the population of 14,416 females who entered basic training at the Great Lakes during the 24 months of recruitment, calcium and vitamin D supplementation for the entire cohort would have prevented about 130 persons per year from fracturing. Such a decrease in SFx would be associated with a significant decrease in morbidity and financial costs.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Female entering basic recruit training at the Great Lakes Naval Station

排除标准

  • 未提供

结局指标

主要结局

individuals with stress fracture

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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