Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02636348
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2015-06-24
Brief Title:
Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training
Sponsor:
United States Army Research Institute of Environmental Medicine
Organization:
United States Army Research Institute of Environmental Medicine
Study Overview
Official Title:
Evaluation of Calcium and Vitamin D Supplementation for Optimizing Bone Health During Marine Corps Recruit Training
Status:
COMPLETED
Status Verified Date:
2016-10
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:
MCRD-PI
Brief Summary:
The primary objective of this randomized double-blind placebo-controlled trial is to determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength in Marine Corps recruits The investigators hypothesize that CaD will prevent elevations in PTH and result in greater increases in indices of bone strength compared to placebo
Detailed Description:
Military recruits undergoing initial military training IMT are 17 times more likely to develop stress fractures compared to active duty service members Up to 800 male and female recruits will be enrolled at the MCRD Parris Island SC over two seasons summerfall and winterspring in order to account for seasonal variation in vitamin D status Ca 2000 mgd and vitamin D 1000 IUd will be supplied as either capsules or a fortified food product daily throughout training This study will provide novel data for the military medical and scientific communities regarding the relationship between Ca and vitamin D supplementation and biomarkers of immune function and the requirements for calcium and vitamin D to support bone health during IMT
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