Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training (MCRD-PI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02636348
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine

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.

Condition or disease Intervention/treatment Phase
Nutrition Status Bone Health Dietary Supplement: Calcium/Vitamin D Dietary Supplement: Placebo Not Applicable

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 (summer/fall and winter/spring) in order to account for seasonal variation in vitamin D status. Ca (2000 mg/d) and vitamin D (1000 IU/d) 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Calcium and Vitamin D Supplementation for Optimizing Bone Health During Marine Corps Recruit Training
Study Start Date : July 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arm Intervention/treatment
Experimental: Calcium/Vitamin D Bar
Dietary supplement consumed as 2 calcium and vitamin D fortified snack bars per day
Dietary Supplement: Calcium/Vitamin D
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.

Experimental: Calcium/Vitamin D Pill
Dietary supplement consumed as several capsules per day
Dietary Supplement: Calcium/Vitamin D
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.

Placebo Comparator: Placebo Bar
Placebo consumed as 2 isocaloric, unfortified snack bars per day
Dietary Supplement: Placebo
Administered daily as 8 placebo pills or 2 unfortified snack bars.

Placebo Comparator: Placebo Pill
Placebo consumed as several capsules per day
Dietary Supplement: Placebo
Administered daily as 8 placebo pills or 2 unfortified snack bars.




Primary Outcome Measures :
  1. Serum Bone Health Biomarkers (Composite) [ Time Frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks ]

    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)



Secondary Outcome Measures :
  1. Bone Strength Indices (Composite) [ Time Frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks ]

    Effect of calcium/vitamin D on the following indices of bone strength as assessed by peripheral quantitative computed tomography (pQCT):

    volumetric bone mineral density (vBMD) (mg/cm3), bone strength index (BSI) (mg/mm4), cortical bone mineral content (Crt BMC) (mg/mm), cortical volumetric bone mineral density (Crt vBMD) (mg/cm3), strength strain index (SSI) (no units)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female Marine Corps recruit at least 17 years of age.

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of kidney stones or kidney disease
  • History of endocrine disorders
  • Allergies to any component of the food product bar

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636348


Locations
Layout table for location information
United States, South Carolina
Marine Corps Recruit Depot Parris Island
Parris Island, South Carolina, United States, 29905
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
Uniformed Services University of the Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Erin Gaffney-Stomberg, Ph.D., R.D. United States Army Research Institute of Environmental Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT02636348    
Other Study ID Numbers: 15-21-HC
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by United States Army Research Institute of Environmental Medicine:
Calcium
Vitamin D
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents