An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers

NCT ID: NCT01100905

Last Updated: 2010-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Military personnel face intense physical and cognitive demands. Diminished iron status affects physiologic responses to these challenges. Both cross-sectional and longitudinal studies indicate a significant decrement in iron status in enlisted female military personnel immediately following basic combat training (BCT). Decrements in iron status are associated with diminished cognitive and physical performance, and may affect body composition. The primary objective of this randomized, placebo controlled study is to assess the utility of an iron-containing food product for maintaining iron status during BCT. This study will provide insight into the utility and efficacy of an iron-containing food product for the maintenance of iron status during military training. Furthermore, it will provide novel scientific data regarding the relationship between iron status and physical and cognitive performance in female Soldiers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Deficiency Iron Deficiency Anemia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iron-containing food product

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female US Army Recruit
* Participating in Basic Combat Training

Exclusion Criteria

* Male
* Pregnancy
* Diagnosed hemochromatosis
* Diagnosed thalassemia
* History of ulcerative colitis
* Allergy to chocolate
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

USARIEM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fort Jackson

Columbia, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Karl JP, Lieberman HR, Cable SJ, Williams KW, Young AJ, McClung JP. Randomized, double-blind, placebo-controlled trial of an iron-fortified food product in female soldiers during military training: relations between iron status, serum hepcidin, and inflammation. Am J Clin Nutr. 2010 Jul;92(1):93-100. doi: 10.3945/ajcn.2010.29185. Epub 2010 May 5.

Reference Type DERIVED
PMID: 20444958 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H08-11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Iron Bioavailability From Cubes
NCT02327299 COMPLETED NA