Nutrition Study of Effect of High Iron Beans on Iron Status

Iron Deficiency Clinical Trial

Official title:

Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594359
• Other study ID #: Project #8209
• Status: Completed
• Phase: N/A
• First received: May 3, 2012
• Last updated: November 30, 2015
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of the study is to determine the efficacy of biofortified beans in improving the iron status of young women in Rwanda.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

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
• BEAN
Placebo

Locations

Country	Name	City	State
Rwanda	National University of Rwanda	Butare	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	HarvestPlus

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved iron status	Improvement in serum ferritin	1 year	No
Secondary	Improved physical and cognitive performance	Tests on physical performance using accelerometers and breath tests; cognitive tests	1 year	No