Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
Information source: Creighton University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stress Fracture
Intervention: Calcium & Vitamin D (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Creighton University Official(s) and/or principal investigator(s): Joan M Lappe, Ph.D., Principal Investigator, Affiliation: Creighton University
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.
Clinical Details
Official title: Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: individuals with stress fracture
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female entering basic recruit training at the Great Lakes Naval Station
Locations and Contacts
Creighton University, Omaha, Nebraska 68131, United States
Additional Information
Starting date: May 2002
Last updated: March 24, 2015
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