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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01594359
Other study ID # Project #8209
Secondary ID
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


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
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