NCT01100905

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.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
Last Updated

April 26, 2010

Status Verified

April 1, 2010

First QC Date

April 7, 2010

Last Update Submit

April 23, 2010

Conditions

Iron DeficiencyIron Deficiency Anemia

Keywords

IronIron statusIron deficiencyIron deficiency anemia

Interventions

Iron-containing food productOTHER

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female US Army Recruit
  • Participating in Basic Combat Training

You may not qualify if:

  • Male
  • Pregnancy
  • Diagnosed hemochromatosis
  • Diagnosed thalassemia
  • History of ulcerative colitis
  • Allergy to chocolate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Jackson

Columbia, South Carolina, 29207, United States

Location

Related Publications (1)

  • 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.

    PMID: 20444958DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
FED

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 9, 2010

Last Updated

April 26, 2010

Record last verified: 2010-04

Locations

US(1)