Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training
MCRD-PI
1 other identifier
interventional
380
1 country
1
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 Ca+D will prevent elevations in PTH and result in greater increases in indices of bone strength compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 28, 2016
October 1, 2016
9 months
June 24, 2015
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum Bone Health Biomarkers (Composite)
Effect of calcium/vitamin D on the following serum biomarkers: 25(OH)D (ng/ml), parathyroid hormone (PTH) (pg/ml), C-telopeptide cross-links of type 1 collagen (CTX) (ng/ml), tartrate-resistant acid phosphatase (TRAP) (U/L), bone alkaline phosphatase (BAP) (ug/L), procollagen I N-terminal peptide (P1NP) (ug/L)
Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Secondary Outcomes (1)
Bone Strength Indices (Composite)
Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Study Arms (4)
Calcium/Vitamin D Bar
EXPERIMENTALDietary supplement consumed as 2 calcium and vitamin D fortified snack bars per day
Calcium/Vitamin D Pill
EXPERIMENTALDietary supplement consumed as several capsules per day
Placebo Bar
PLACEBO COMPARATORPlacebo consumed as 2 isocaloric, unfortified snack bars per day
Placebo Pill
PLACEBO COMPARATORPlacebo consumed as several capsules per day
Interventions
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.
Administered daily as 8 placebo pills or 2 unfortified snack bars.
Eligibility Criteria
You may qualify if:
- Male or female Marine Corps recruit at least 17 years of age.
You may not qualify if:
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
- History of endocrine disorders
- Allergies to any component of the food product bar
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marine Corps Recruit Depot Parris Island
Parris Island, South Carolina, 29905, United States
Related Publications (1)
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.
PMID: 30615068DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Gaffney-Stomberg, Ph.D., R.D.
United States Army Research Institute of Environmental Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
December 21, 2015
Study Start
July 1, 2015
Primary Completion
April 1, 2016
Study Completion
October 1, 2016
Last Updated
October 28, 2016
Record last verified: 2016-10