Optimizing Vitamin D Status During Initial Military Training
NCT ID: NCT01617109
Last Updated: 2018-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
342 participants
INTERVENTIONAL
2012-06-30
2018-05-02
Brief Summary
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The investigators hypothesize that daily supplementation with vitamin D and calcium during military training will improve vitamin D status, stabilize PTH levels, and result in improvements in markers of bone health. As a result of the investigators study design, the findings will provide critically important data regarding the concentration of vitamin D in blood necessary to stabilize PTH levels and to optimize bone formation during initial military training.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo
administered as 5 pills daily or as 2 snack bars
Ca/Vit D
Ca/Vit D
800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars
Interventions
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Ca/Vit D
800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars
Placebo
administered as 5 pills daily or as 2 snack bars
Eligibility Criteria
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Inclusion Criteria
* Participating in Basic Combat Training or Basic Military Training, respectively
Exclusion Criteria
* History of kidney stones or kidney disease
17 Years
42 Years
ALL
Yes
Sponsors
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United States Army Research Institute of Environmental Medicine
FED
Responsible Party
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Principal Investigators
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James P McClung, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
US Army Research Institute of Environmental Medicine
Locations
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Fort Sill
Fort Sill, Oklahoma, United States
Lackland Air Force Base
San Antonio, Texas, United States
Countries
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References
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Andersen NE, Karl JP, Cable SJ, Williams KW, Rood JC, Young AJ, Lieberman HR, McClung JP. Vitamin D status in female military personnel during combat training. J Int Soc Sports Nutr. 2010 Dec 14;7:38. doi: 10.1186/1550-2783-7-38.
Nakayama AT, Lutz LJ, Hruby A, Karl JP, McClung JP, Gaffney-Stomberg E. A dietary pattern rich in calcium, potassium, and protein is associated with tibia bone mineral content and strength in young adults entering initial military training. Am J Clin Nutr. 2019 Jan 1;109(1):186-196. doi: 10.1093/ajcn/nqy199.
Lutz LJ, Gaffney-Stomberg E, Karl JP, Hughes JM, Guerriere KI, McClung JP. Dietary Intake in Relation to Military Dietary Reference Values During Army Basic Combat Training; a Multi-center, Cross-sectional Study. Mil Med. 2019 Mar 1;184(3-4):e223-e230. doi: 10.1093/milmed/usy153.
Gaffney-Stomberg E, Lutz LJ, Rood JC, Cable SJ, Pasiakos SM, Young AJ, McClung JP. Calcium and vitamin D supplementation maintains parathyroid hormone and improves bone density during initial military training: a randomized, double-blind, placebo controlled trial. Bone. 2014 Nov;68:46-56. doi: 10.1016/j.bone.2014.08.002. Epub 2014 Aug 10.
Other Identifiers
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H12-09; 13-24HC
Identifier Type: -
Identifier Source: org_study_id
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