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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00476346
First received: May 18, 2007
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Stress Fracture
Procedure: calcium and vitamin D supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • individuals with stress fracture [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 5201
Study Start Date: May 2002
Study Completion Date: March 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female entering basic recruit training at the Great Lakes Naval Station
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00476346

Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
GlaxoSmithKline
Investigators
Principal Investigator: Joan M Lappe, Ph.D. Creighton University
  More Information

No publications provided

Responsible Party: Joan M. Lappe, Creighton University
ClinicalTrials.gov Identifier: NCT00476346     History of Changes
Other Study ID Numbers: DAMD-17-01-1-0807
Study First Received: May 18, 2007
Last Updated: August 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
physical training
military training
bone
fracture prevention
young adult

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Stress
Wounds and Injuries
Vitamin D
Ergocalciferols
Vitamins
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014