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

Primary Purpose

Stress Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calcium & Vitamin D
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Fracture focused on measuring physical training, military training, bone, fracture prevention, young adult

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Calcium

Vitamin D

Arm Description

Daily calcium supplementation Intervention: Calcium 2000mg / daily

Daily Calcium and Vitamin D supplementation Intervention: Vitamin D 800IU / daily

Outcomes

Primary Outcome Measures

individuals with stress fracture

Secondary Outcome Measures

Full Information

First Posted
May 18, 2007
Last Updated
March 24, 2015
Sponsor
Creighton University
Collaborators
GlaxoSmithKline, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00476346
Brief Title
Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
Official Title
Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Creighton University
Collaborators
GlaxoSmithKline, United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Fracture
Keywords
physical training, military training, bone, fracture prevention, young adult

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium
Arm Type
Active Comparator
Arm Description
Daily calcium supplementation Intervention: Calcium 2000mg / daily
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Daily Calcium and Vitamin D supplementation Intervention: Vitamin D 800IU / daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium & Vitamin D
Intervention Description
Calcium 2000mg / daily Vitamin D 800IU / daily
Primary Outcome Measure Information:
Title
individuals with stress fracture
Time Frame
one year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female entering basic recruit training at the Great Lakes Naval Station
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan M Lappe, Ph.D.
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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