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NCT01100905 Clinical Trial

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

Iron Deficiency Anemia Clinical Trial

Official title:
Utility of an Iron-containing Food Product for the Prevention of Diminished Iron Status During Basic Combat Training

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01100905
Other study ID # H08-11
Secondary ID
Status Completed
Phase N/A
First received April 7, 2010
Last updated April 23, 2010

Study information
Verified date April 2010
Source United States Army Research Institute of Environmental Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 42 Years
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Other:
• Iron-containing food product

Locations
Country Name City State
United States Fort Jackson Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

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