NCT02375503

Brief Summary

The primary objective of this randomized, double-blind, placebo controlled trial is to determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified food product on bone turnover markers, including parathyroid hormone (PTH) and microarchitecture during Army basic military training (BCT). The investigators hypothesize that consumption of a once daily calcium and vitamin D fortified food product will stabilize PTH and contribute to improved bone microarchitecture compared to placebo. The results will determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover markers as well as provide novel data regarding microarchitectural changes during BCT as assessed by high resolution peripheral computed tomography (HRpQCT) scanning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

February 24, 2015

Last Update Submit

May 12, 2017

Conditions

Bone AlterationDietary Modification

Keywords

CalciumVitamin DParathyroid HormoneBoneMicroarchitecture

Outcome Measures

Primary Outcomes (1)

  • Bone Turnover Markers

    Participants will have a pre- and post- BCT blood draw

    8-10 weeks

Secondary Outcomes (1)

  • Bone Microarchitecture

    8-10 weeks

Study Arms (2)

Calcium/Vitamin D

EXPERIMENTAL

Dietary supplement distributed and consumed as one calcium and vitamin D fortified snack bar per day

Dietary Supplement: Calcium/Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo distributed and consumed as one isocaloric, unfortified snack bar per day

Dietary Supplement: Placebo

Interventions

Calcium/Vitamin DDIETARY_SUPPLEMENT

Daily, calcium and vitamin D fortified snack bar

Calcium/Vitamin D
PlaceboDIETARY_SUPPLEMENT
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 recruits beginning Army basic combat training at Fort Jackson, South Carolina

You may not qualify if:

  • Pregnant or breastfeeding
  • History of kidney stones or kidney disease
  • History of amenorrhea
  • History or endocrine disorders
  • History of bone modifying disorders
  • Currently taking, or have taken glucocorticoid drugs in the 2 years prior to study participation
  • Currently diagnosed as anemic by healthcare professional
  • Those allergic to any component of the snack bar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Jackson

Columbia, South Carolina, 29207, United States

Location

Related Publications (1)

  • 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

MeSH Terms

Interventions

CalciumVitamin D

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Erin Gaffney-Stomberg, Ph.D., R.D.

    U.S. 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

February 24, 2015

First Posted

March 2, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

US(1)