Nutrition Study of Effect of High Iron Beans on Iron Status

This study has been completed.
Sponsor:
Collaborator:
HarvestPlus
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01594359
First received: May 3, 2012
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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 Intervention
Iron Deficiency
Other: Biofortified beans
Other: BEAN

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Improved iron status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Improvement in serum ferritin


Secondary Outcome Measures:
  • Improved physical and cognitive performance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Tests on physical performance using accelerometers and breath tests; cognitive tests


Enrollment: 300
Study Start Date: August 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594359

Locations
Rwanda
National University of Rwanda
Butare, Kigali, Rwanda
Kigali, Rwanda
Sponsors and Collaborators
Swiss Federal Institute of Technology
HarvestPlus
Investigators
Principal Investigator: Richard F. Hurrell, PhD University of Zurich
  More Information

Responsible Party: Prof. Michael B. Zimmermann, Principle Investigator, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01594359     History of Changes
Other Study ID Numbers: Project #8209 
Study First Received: May 3, 2012
Last Updated: November 30, 2015
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Federal Institute of Technology:
Ferritin

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016