NCT01594359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

May 3, 2012

Last Update Submit

November 30, 2015

Conditions

Iron Deficiency

Keywords

Ferritin

Outcome Measures

Primary Outcomes (1)

  • Improved iron status

    Improvement in serum ferritin

    1 year

Secondary Outcomes (1)

  • Improved physical and cognitive performance

    1 year

Study Arms (2)

High iron bean

ACTIVE COMPARATOR

High-iron bean

Other: Biofortified beans

Low iron bean

PLACEBO COMPARATOR

Low-iron bean

Other: BEAN

Interventions

Biofortified beansOTHER

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

High iron bean
BEANOTHER

Placebo

Low iron bean

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University of Rwanda

Butare, Kigali, Rwanda

Location

Unknown Facility

Kigali, Kigali, Rwanda

Location

Related Publications (4)

  • Luna SV, Pompano LM, Lung'aho M, Gahutu JB, Haas JD. Increased Iron Status during a Feeding Trial of Iron-Biofortified Beans Increases Physical Work Efficiency in Rwandan Women. J Nutr. 2020 May 1;150(5):1093-1099. doi: 10.1093/jn/nxaa016.

    PMID: 32006009DERIVED

  • Wenger MJ, Rhoten SE, Murray-Kolb LE, Scott SP, Boy E, Gahutu JB, Haas JD. Changes in Iron Status Are Related to Changes in Brain Activity and Behavior in Rwandan Female University Students: Results from a Randomized Controlled Efficacy Trial Involving Iron-Biofortified Beans. J Nutr. 2019 Apr 1;149(4):687-697. doi: 10.1093/jn/nxy265.

    PMID: 30926992DERIVED

  • Murray-Kolb LE, Wenger MJ, Scott SP, Rhoten SE, Lung'aho MG, Haas JD. Consumption of Iron-Biofortified Beans Positively Affects Cognitive Performance in 18- to 27-Year-Old Rwandan Female College Students in an 18-Week Randomized Controlled Efficacy Trial. J Nutr. 2017 Nov;147(11):2109-2117. doi: 10.3945/jn.117.255356. Epub 2017 Sep 27.

    PMID: 28954841DERIVED

  • Haas JD, Luna SV, Lung'aho MG, Wenger MJ, Murray-Kolb LE, Beebe S, Gahutu JB, Egli IM. Consuming Iron Biofortified Beans Increases Iron Status in Rwandan Women after 128 Days in a Randomized Controlled Feeding Trial. J Nutr. 2016 Aug;146(8):1586-92. doi: 10.3945/jn.115.224741. Epub 2016 Jun 29.

    PMID: 27358417DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Richard F. Hurrell, PhD

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 9, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

RW(2)