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Nutrition Study of Effect of High Iron Beans on Iron Status

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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

Tracking Information
First Submitted Date  ICMJE May 3, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
Improved iron status [ Time Frame: 1 year ]
Improvement in serum ferritin
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
Improved physical and cognitive performance [ Time Frame: 1 year ]
Tests on physical performance using accelerometers and breath tests; cognitive tests
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition Study of Effect of High Iron Beans on Iron Status
Official Title  ICMJE Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Iron Deficiency
Intervention  ICMJE
  • 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
  • Other: BEAN
    Placebo
Study Arms  ICMJE
  • Active Comparator: High iron bean
    High-iron bean
    Intervention: Other: Biofortified beans
  • Placebo Comparator: Low iron bean
    Low-iron bean
    Intervention: Other: BEAN
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2012)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Rwanda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594359
Other Study ID Numbers  ICMJE Project #8209
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Study Sponsor  ICMJE Swiss Federal Institute of Technology
Collaborators  ICMJE HarvestPlus
Investigators  ICMJE
Principal Investigator: Richard F. Hurrell, PhD ETH Zurich
PRS Account Swiss Federal Institute of Technology
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP