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

Primary Purpose

Iron Deficiency, Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iron-containing food product
Sponsored by
United States Army Research Institute of Environmental Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Iron Deficiency focused on measuring Iron, Iron status, Iron deficiency, Iron deficiency anemia

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fort Jackson

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2010
Last Updated
April 23, 2010
Sponsor
United States Army Research Institute of Environmental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01100905
Brief Title
An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers
Official Title
Utility of an Iron-containing Food Product for the Prevention of Diminished Iron Status During Basic Combat Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
United States Army Research Institute of Environmental Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Iron Deficiency Anemia
Keywords
Iron, Iron status, Iron deficiency, Iron deficiency anemia

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Iron-containing food product

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fort Jackson
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20444958
Citation
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.
Results Reference
derived

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

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