Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476346
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2007-05-18
Brief Title:
Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Calcium and Vitamin D Supplementation Decreases Incidence of Stress Fractures in Female Navy Recruits
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Dday decreased incidence of stress fracture by 25 The hypothesis was
Supplementation with calcium 2000 mgd and vitamin D 800 IUd will significantly reduce the incidence of stress fractures in female Navy recruits during 8 weeks of basic training
Supplementation with calcium 2000 mgd and vitamin D 800 IUd 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 supplementday 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 59 per eight weeks Using intention-to-treat analysis by including all enrolled subjects Fishers Exact test found that the calcium and vitamin D group had a 25 lower incidence of SFx than the control group 66 vs 53 respectively p003 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 86 vs 68 respectively p002
Conclusions Generalizing the findings to the population of 14416 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
Methods We recruited 5201 female Navy recruit volunteers and randomized them to a 2000 mg calcium and 800 IU vitamin D supplementday 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 59 per eight weeks Using intention-to-treat analysis by including all enrolled subjects Fishers Exact test found that the calcium and vitamin D group had a 25 lower incidence of SFx than the control group 66 vs 53 respectively p003 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 86 vs 68 respectively p002
Conclusions Generalizing the findings to the population of 14416 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None