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Nutrition Study of Effect of High Iron Beans on Iron Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01594359
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Brief Summary:
The purpose of this study is to determine whether beans bred to have a high iron content are effective in improving the iron status of young women.

Condition or disease Intervention/treatment Phase
Iron Deficiency Other: Biofortified beans Other: BEAN Not Applicable

Detailed Description:
The goal of the study is to determine the efficacy of biofortified beans in improving the iron status of young women in Rwanda.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial
Study Start Date : August 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: High iron bean
High-iron bean
Other: Biofortified beans
Comparison of two types of the common bean that are similar in all aspects except their iron concentration - one has a high iron concentration while the other has low iron concentration

Placebo Comparator: Low iron bean
Low-iron bean
Other: BEAN

Primary Outcome Measures :
  1. Improved iron status [ Time Frame: 1 year ]
    Improvement in serum ferritin

Secondary Outcome Measures :
  1. Improved physical and cognitive performance [ Time Frame: 1 year ]
    Tests on physical performance using accelerometers and breath tests; cognitive tests

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study

Exclusion Criteria:

  • Pregnant, lactating, severe anemia, low BMI would be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01594359

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National University of Rwanda
Butare, Kigali, Rwanda
Kigali, Rwanda
Sponsors and Collaborators
Swiss Federal Institute of Technology
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Principal Investigator: Richard F. Hurrell, PhD ETH Zurich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Michael B. Zimmermann, Principle Investigator, Swiss Federal Institute of Technology Identifier: NCT01594359    
Other Study ID Numbers: Project #8209
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology:
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases