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

Stress Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476346
• Other study ID #: DAMD-17-01-1-0807
• Status: Completed
• Phase: N/A
• First received: May 18, 2007
• Last updated: March 24, 2015
• Start date: May 2002
• Est. completion date: March 2006

Study information

• Verified date: August 2008
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5201
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Stress Fracture

Intervention

Dietary Supplement:
• Calcium & Vitamin D
Calcium 2000mg / daily Vitamin D 800IU / daily

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
Creighton University	GlaxoSmithKline, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	individuals with stress fracture		one year	No