Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
1 other identifier
interventional
5,201
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 22, 2007
CompletedMarch 25, 2015
August 1, 2008
May 18, 2007
March 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
individuals with stress fracture
one year
Study Arms (2)
Calcium
ACTIVE COMPARATORDaily calcium supplementation Intervention: Calcium 2000mg / daily
Vitamin D
EXPERIMENTALDaily Calcium and Vitamin D supplementation Intervention: Vitamin D 800IU / daily
Interventions
Eligibility Criteria
You may qualify if:
- Female entering basic recruit training at the Great Lakes Naval Station
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Creighton Universitylead
- GlaxoSmithKlinecollaborator
- United States Department of Defensecollaborator
Study Sites (1)
Creighton University
Omaha, Nebraska, 68131, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan M Lappe, Ph.D.
Creighton University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 22, 2007
Study Start
May 1, 2002
Study Completion
March 1, 2006
Last Updated
March 25, 2015
Record last verified: 2008-08