Iron DeficiencyNCT01594359
Nutrition Study of Effect of High Iron Beans on Iron Status
A study testing Biofortified beans and BEAN in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 2 sites in Rwanda.
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. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Biofortified beans and BEAN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesRwanda
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant, lactating, severe anemia, low BMI would be excluded
Trial locations and contacts
2 sites in 1 country.
Rwanda2 sites
National University of Rwanda
Butare, Kigali
Study site
Kigali, Kigali
About this study
Official title: Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Iron Deficiency
- Being tested
- Biofortified beans, BEAN
- Keywords
- Ferritin
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
BEANOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| High iron bean | Active comparator | High-iron bean Receives: Other: Biofortified beans |
| Low iron bean | Placebo comparator | Low-iron bean Receives: Other: BEAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved iron status
Improvement in serum ferritin
Measured: 1 year
Secondary outcomes (1)
Improved physical and cognitive performance
Tests on physical performance using accelerometers and breath tests; cognitive tests
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- HarvestPlus
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Richard F. Hurrell, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594359
- Sponsor's protocol ID
- Project #8209
- Status last verified
- Nov 2015
- First submitted
- 3 May 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32006009Wenger 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.
PubMed 30926992Murray-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.
PubMed 28954841Haas 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.
PubMed 27358417
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01594359
- Acronym / sponsor ID
- Project #8209
- Conditions
- Iron Deficiency
- Keywords
- Ferritin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- HarvestPlus
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High iron bean | Active comparator | Other: Biofortified beansHigh-iron bean |
| Low iron bean | Placebo comparator | Other: BEANLow-iron bean |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant, lactating, severe anemia, low BMI would be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofortified beansComparison 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 | Other | High iron bean |
| BEANPlacebo | Other | Low iron bean |
Primary outcome
Improved iron status
Time frame: 1 year
Improvement in serum ferritin
1 secondary outcome
Improved physical and cognitive performance
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 32006009Luna 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.
- Derived from this study: PubMed 30926992Wenger 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.
- Derived from this study: PubMed 28954841Murray-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.
- Derived from this study: PubMed 27358417Haas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard F. Hurrell, PhD principal investigator
ETH Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofortified beans and BEAN in people with Iron Deficiency, run by Swiss Federal Institute of Technology at 2 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved iron status (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594359, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.