NCT01617109

Brief Summary

The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the effect of vitamin D and calcium supplementation (800IU and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during Army basic combat training (BCT) and Air Force basic military training (BMT). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

June 1, 2012

Last Update Submit

October 10, 2018

Conditions

Bone HealthNutrition Status

Keywords

Vitamin DCalciumParathyroid hormoneBoneBone formationBone resorptionMicronutrientsTrace Elements

Outcome Measures

Primary Outcomes (1)

  • Serum PTH pg/ml

    Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Ca/Vit D

EXPERIMENTAL
Dietary Supplement: Ca/Vit D

Interventions

Ca/Vit DDIETARY_SUPPLEMENT

800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars

Ca/Vit D
PlaceboOTHER

administered as 5 pills daily or as 2 snack bars

Placebo

Eligibility Criteria

Age17 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female or male US Army or US Air Force Recruits
  • Participating in Basic Combat Training or Basic Military Training, respectively

You may not qualify if:

  • Pregnant or breastfeeding
  • History of kidney stones or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fort Sill

Fort Sill, Oklahoma, 73503, United States

Location

Lackland Air Force Base

San Antonio, Texas, 78236, United States

Location

Related Publications (4)

  • 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.

    PMID: 21156069BACKGROUND

  • 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

  • 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.

    PMID: 29982620DERIVED

  • 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.

    PMID: 25118085DERIVED

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • James P McClung, Ph.D.

    US Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

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 1, 2012

First Posted

June 12, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2014

Study Completion

May 2, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

US(2)