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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.
 
ClinicalTrials.gov Identifier: NCT01594359
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
HarvestPlus
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Study Description
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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.
Study Design
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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

Arms and Interventions
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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
Placebo


Outcome Measures
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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


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01594359


Locations
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Rwanda
National University of Rwanda
Butare, Kigali, Rwanda
Kigali, Rwanda
Sponsors and Collaborators
Swiss Federal Institute of Technology
HarvestPlus
Investigators
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Principal Investigator: Richard F. Hurrell, PhD ETH Zurich
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Michael B. Zimmermann, Principle Investigator, Swiss Federal Institute of Technology
ClinicalTrials.gov 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:
Ferritin
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
 Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases