Efficacy of a Once Daily Calcium and Vitamin D Fortified... | NCT02375503

Studies
Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture

NCT02375503

Sponsor

United States Army Research Institute of Environmental Medicine

Status

Completed

Last Update Posted

May 15, 2017Actual

Enrollment

175Actual

Phase

Not Applicable

Conditions

Bone Alteration
Dietary Modification

Interventions

Calcium/Vitamin D
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 24, 2015

First Submission Date that Met QC Criteria

Feb 27, 2015

First Posted Date

Mar 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2017

Last Update Posted Date

May 15, 2017Actual

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Stress fractures may affect up to 2-5% of male and 8-21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel. A recent report indicates that supplemental calcium (2000mg) and vitamin D (800-1000IU) stabilizes PTH, increases tibia volumetric bone mineral density in male and female recruits undergoing Army BCT, and reduces stress fracture incidence by up to 20% in female Nacy recruits. Bone macroarchitecture has been measured in response to basic training however, the resolution of standard peripheral quantitative computed tomography (pQCT) is insufficient for assessment of microarchitectural changes, which may underlie the pathophysiology of stress fracture. With the use of HRpQCT this study will allow the investigators to evaluate microarchitectural changes within the bone tissue and assess the efficacy of a moderate daily dose of calcium and vitamin D to support bone health during BCT.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Calcium/Vitamin D	Dietary Supplement	Daily, calcium and vitamin D fortified snack bar	Calcium/Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone Turnover Markers	Participants will have a pre- and post- BCT blood draw	8-10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Bone Microarchitecture	Participants will receive a bone scan pre- and post- BCT in order to determine changes in bone microarchitecture	8-10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female or male US Army recruits beginning Army basic combat training at Fort Jackson, South Carolina

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

42 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erin Gaffney-Stomberg, Ph.D., R.D.	U.S. Army Research Institute of Environmental Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fort Jackson		Columbia	South Carolina	29207	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29982620	Derived	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.

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals