Stress FractureNCT00476346
Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
A study testing Calcium & Vitamin D in people with Stress Fracture, run by Creighton University at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Fracture
- What is being tested?
- Calcium & Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,201 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female entering basic recruit training at the Great Lakes Naval Station
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress Fracture
- Being tested
- Calcium & Vitamin D
- Keywords
- physical training, military training, bone, fracture prevention, young adult
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium & Vitamin DDietary supplement
Calcium 2000mg / daily Vitamin D 800IU / daily
| Study group | Role | What they receive |
|---|---|---|
| Calcium | Active comparator | Daily calcium supplementation Intervention: Calcium 2000mg / daily Receives: Dietary Supplement: Calcium & Vitamin D |
| Vitamin D | Experimental | Daily Calcium and Vitamin D supplementation Intervention: Vitamin D 800IU / daily Receives: Dietary Supplement: Calcium & Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
individuals with stress fracture
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMay 2002
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, United States Department of Defense
- Investigators
- Joan M Lappe, Ph.D., Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476346
- Sponsor's protocol ID
- DAMD-17-01-1-0807
- Status last verified
- Aug 2008
- First submitted
- 18 May 2007
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
- ClinicalTrials.gov ID
- NCT00476346
- Acronym / sponsor ID
- DAMD-17-01-1-0807
- Conditions
- Stress Fracture
- Keywords
- physical training, military training, bone, fracture prevention, young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,201 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, United States Department of Defense
- Study start
- May 2002
- Study completion
- Mar 2006 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium | Active comparator | Dietary Supplement: Calcium & Vitamin DDaily calcium supplementation Intervention: Calcium 2000mg / daily |
| Vitamin D | Experimental | Dietary Supplement: Calcium & Vitamin DDaily Calcium and Vitamin D supplementation Intervention: Vitamin D 800IU / daily |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female entering basic recruit training at the Great Lakes Naval Station
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium & Vitamin DCalcium 2000mg / daily Vitamin D 800IU / daily | Dietary supplement | Calcium, Vitamin D |
Primary outcome
individuals with stress fracture
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
Related trials for Stress Fracture
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
RecruitingObservational study
Bone Stress Injury Recovery and Return to Sport: A Natural History Study
Bone Stress Fracture
RecruitingPhase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Acute Stress Reaction, Acute Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan M Lappe, Ph.D. principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium & Vitamin D in people with Stress Fracture, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
individuals with stress fracture (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.