Nutrition Study of Effect of High Iron Beans on Iron Status

This study is currently recruiting participants.

Verified November 2012 by Swiss Federal Institute of Technology

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 7, 2012

Last verified: November 2012

History of Changes

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:

MedlinePlus related topics: Iron

U.S. FDA Resources

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

Estimated Enrollment:	300
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2013 (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
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

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

Contacts

Contact: Ines M Egli, PhD	+44 632 86 45	ines.egli@hest.ethz.ch
Contact: Richard F. Hurrell, PhD	+44 632 84 20	richard.hurrell@hest.ethz.ch

Locations

Rwanda
National University of Rwanda	Recruiting
Butare, Kigali, Rwanda
Contact: Jean-Bosco Gahutu, Phd Med Dr
Sub-Investigator: Jean-Bosco Gahutu, PhD
	Recruiting
Kigali, Rwanda

Sponsors and Collaborators

Swiss Federal Institute of Technology

HarvestPlus

Investigators

Principal Investigator:

Richard F. Hurrell, PhD

ETH Zurich

More Information

No publications provided

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 7, 2012
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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