Iron-deficiencyNCT03835377
Iron-Biofortified Beans Intervention in Mexico
A study testing Iron-biofortified beans in people with Iron-deficiency and Anemia, run by Cornell University at 1 site in Mexico.
Trial summary
The objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans). Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Anemia
- What is being tested?
- Iron-biofortified beans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jan 2010to 15 Aug 2010
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Boarding schools for children (5-12 y)
- Located in a rural area approximately 60 kilometers east of the city of Oaxaca
- A high prevalence of anemia (>=15.0%) on the baseline survey
- Adequate infrastructure to sustain a 6-month feeding trial. Exclusion criteria were a prevalence of anemia of less than 15% on the baseline survey, and inadequate infrastructure to sustain a 6-month feeding trial
Who cannot join
- A prevalence of anemia <15.0% on the baseline survey
- Inadequate infrastructure to sustain a 6-month feeding trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Feeding Trial of Iron-Biofortified Beans in School Children in Mexico
The objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans). A cluster-randomized trial of biofortified beans (Phaseolus vulgaris L), bred to enhance iron content, was conducted for 6 months.
Read the detailed description
Iron deficiency is the most common single nutrient deficiency worldwide, with the highest burden in children and women of reproductive age. Global estimates of anemia prevalence in school-aged children range between 25% and 46%, and iron deficiency accounts for a majority of anemia cases. In Mexico, the national nutrition and health survey (2006) reported a prevalence of anemia of 16.6% and iron deficiency of 17.6% (serum ferritin <12.0 µg/L), posing a considerable health risk for children.
Interventions, including micronutrient supplementation and food fortification, have improved iron status and reduced the prevalence of anemia in some settings. However, iron deficiency remains an urgent public health problem and threat to child health and development. Young children are particularly at high risk due to rapid growth, inadequate dietary intake, and high risk of infection in resource-limited settings. Iron deficiency has been associated with impaired cognitive function in children, and long-term impairments in physical work capacity into adulthood.
One novel approach to reducing micronutrient malnutrition is to enhance the nutrient quality of the diet through biofortification of staple crops that are already locally accepted and consumed. Biofortification has consequently been recognized by the Copenhagen Consensus of 2008 as one of the top five solutions to current global health and nutrition challenges. The success and challenges of biofortification have been documented previously. We recently reviewed the published evidence from the three randomized efficacy trials of different iron-biofortified crops that demonstrated varied benefits in populations, including rice in adult Filipino women, pearl millet in school-aged children in India, and beans in women of reproductive age in Rwanda. Findings demonstrated improvements in serum ferritin concentrations and total body iron concentrations, with additional potential to benefit in individuals who were iron deficient at baseline. Given this limited evidence and with no studies from Latin America, more studies with diverse populations and locally relevant crops are warranted before implementation of a potentially important public health intervention.
In order to target at-risk populations in Latin America, the Centro Internacional de Agricultura Tropical (CIAT) in Colombia bred and biofortified a common black bean variety (Phaseolus vulgaris L), the standard black bean currently consumed widely in Central America and Mexico. In Mexico, beans have been ranked highly among the most consumed foods by school-aged children nationwide, according to Encuesta Nacional de Salud y Nutrición, a nationally representative nutrition survey in 2006. Biofortification has nearly doubled the iron concentration (~100 versus ~50 mg/kg) of the standard bean variety. We hypothesized that daily consumption of iron-biofortified beans (Fe-Beans) would improve hemoglobin, serum ferritin, and total body iron in 6 months, compared to control beans (Control-Beans). In order to examine this hypothesis, we conducted the first randomized efficacy trial of iron-biofortified beans and iron status in primary school-aged children in a low-income setting in Mexico. Special consideration was applied to assess indicators of iron status with and without anemia and measured inflammatory markers, which can mask iron deficiency, particularly in similar settings where the prevalence of infection is high.
The objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans).
The long-term goal of this study is to determine if iron bio-fortification of beans is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.
- Conditions
- Iron-deficiency, Anemia
- Being tested
- Iron-biofortified beans, Control beans
- Keywords
- Iron, Biofortification, Iron deficiency, Anemia, Children, Mexico
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-biofortified beansOther
Also called Fe-Beans
Iron-biofortified beans (Phaseolus vulgaris L MIB465)
Control beansOther
Also called Control-Beans
Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size
| Study group | Role | What they receive |
|---|---|---|
| Iron-biofortified beans | Experimental | Iron-biofortified beans (Phaseolus vulgaris L MIB465) Receives: Other: Iron-biofortified beans |
| Control beans | Active comparator | Control beans (Phaseolus vulgaris L Jamapa variety) Receives: Other: Control beans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
Hemoglobin (Hb)
Measured: 6 months
Change in serum ferritin
Serum ferritin (SF)
Measured: 6 months
Change in sTfR
Soluble transferrin receptor (sTfR)
Measured: 6 months
Anemia
Hb <115 g/L for <12 y; <120 g/L for >=12 y
Measured: 6 months
Iron deficiency (SF)
Serum ferritin <15.0 µg/L
Measured: 6 months
Secondary outcomes (3)
Change in TBI
Total body iron (TBI)
Measured: 6 months
Iron deficiency (TBI)
TBI <0.0 mg/kg
Measured: 6 months
Iron deficiency (sTfr)
sTfr >8.3 μg/mL
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start6 Jan 2010
- Primary completion25 Jun 2010
- Study completion15 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Salud Publica, Mexico
- Responsible party
- Sponsor
- Investigators
- Salvador Villalpando, MD PhD, Principal investigator, Instituto Nacional de Salud Publica (INSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835377
- Sponsor's protocol ID
- CI-441
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finkelstein JL, Mehta S, Villalpando S, Mundo-Rosas V, Luna SV, Rahn M, Shamah-Levy T, Beebe SE, Haas JD. A Randomized Feeding Trial of Iron-Biofortified Beans on School Children in Mexico. Nutrients. 2019 Feb 12;11(2):381. doi: 10.3390/nu11020381.
PubMed 30759887
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feeding Trial of Iron-Biofortified Beans in School Children in Mexico
- ClinicalTrials.gov ID
- NCT03835377
- Acronym / sponsor ID
- CI-441
- Conditions
- Iron-deficiency, Anemia
- Keywords
- Iron, Biofortification, Iron deficiency, Anemia, Children, Mexico
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Instituto Nacional de Salud Publica, Mexico
- Study start
- 6 Jan 2010 (actual)
- Primary completion
- 25 Jun 2010 (actual)
- Study completion
- 15 Aug 2010 (actual)
- First posted
- 8 Feb 2019 (actual)
- 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 objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans). A cluster-randomized trial of biofortified beans (Phaseolus vulgaris L), bred to enhance iron content, was conducted for 6 months.
Detailed description
Iron deficiency is the most common single nutrient deficiency worldwide, with the highest burden in children and women of reproductive age. Global estimates of anemia prevalence in school-aged children range between 25% and 46%, and iron deficiency accounts for a majority of anemia cases. In Mexico, the national nutrition and health survey (2006) reported a prevalence of anemia of 16.6% and iron deficiency of 17.6% (serum ferritin <12.0 µg/L), posing a considerable health risk for children.
Interventions, including micronutrient supplementation and food fortification, have improved iron status and reduced the prevalence of anemia in some settings. However, iron deficiency remains an urgent public health problem and threat to child health and development. Young children are particularly at high risk due to rapid growth, inadequate dietary intake, and high risk of infection in resource-limited settings. Iron deficiency has been associated with impaired cognitive function in children, and long-term impairments in physical work capacity into adulthood.
One novel approach to reducing micronutrient malnutrition is to enhance the nutrient quality of the diet through biofortification of staple crops that are already locally accepted and consumed. Biofortification has consequently been recognized by the Copenhagen Consensus of 2008 as one of the top five solutions to current global health and nutrition challenges. The success and challenges of biofortification have been documented previously. We recently reviewed the published evidence from the three randomized efficacy trials of different iron-biofortified crops that demonstrated varied benefits in populations, including rice in adult Filipino women, pearl millet in school-aged children in India, and beans in women of reproductive age in Rwanda. Findings demonstrated improvements in serum ferritin concentrations and total body iron concentrations, with additional potential to benefit in individuals who were iron deficient at baseline. Given this limited evidence and with no studies from Latin America, more studies with diverse populations and locally relevant crops are warranted before implementation of a potentially important public health intervention.
In order to target at-risk populations in Latin America, the Centro Internacional de Agricultura Tropical (CIAT) in Colombia bred and biofortified a common black bean variety (Phaseolus vulgaris L), the standard black bean currently consumed widely in Central America and Mexico. In Mexico, beans have been ranked highly among the most consumed foods by school-aged children nationwide, according to Encuesta Nacional de Salud y Nutrición, a nationally representative nutrition survey in 2006. Biofortification has nearly doubled the iron concentration (~100 versus ~50 mg/kg) of the standard bean variety. We hypothesized that daily consumption of iron-biofortified beans (Fe-Beans) would improve hemoglobin, serum ferritin, and total body iron in 6 months, compared to control beans (Control-Beans). In order to examine this hypothesis, we conducted the first randomized efficacy trial of iron-biofortified beans and iron status in primary school-aged children in a low-income setting in Mexico. Special consideration was applied to assess indicators of iron status with and without anemia and measured inflammatory markers, which can mask iron deficiency, particularly in similar settings where the prevalence of infection is high.
The objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans).
The long-term goal of this study is to determine if iron bio-fortification of beans is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron-biofortified beans | Experimental | Other: Iron-biofortified beansIron-biofortified beans (Phaseolus vulgaris L MIB465) |
| Control beans | Active comparator | Other: Control beansControl beans (Phaseolus vulgaris L Jamapa variety) |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Boarding schools for children (5-12 y)
- Located in a rural area approximately 60 kilometers east of the city of Oaxaca
- A high prevalence of anemia (>=15.0%) on the baseline survey
- Adequate infrastructure to sustain a 6-month feeding trial. Exclusion criteria were a prevalence of anemia of less than 15% on the baseline survey, and inadequate infrastructure to sustain a 6-month feeding trial
Key exclusion criteria (2 listed)
- A prevalence of anemia <15.0% on the baseline survey
- Inadequate infrastructure to sustain a 6-month feeding trial
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 |
|---|---|---|
| Iron-biofortified beansAlso: Fe-BeansIron-biofortified beans (Phaseolus vulgaris L MIB465) | Other | Iron-biofortified beans |
| Control beansAlso: Control-BeansControl beans (Phaseolus vulgaris L Jamapa variety), identical in color and size | Other | Control beans |
Primary outcome
Change in hemoglobin
Time frame: 6 months
Hemoglobin (Hb)
Change in serum ferritin
Time frame: 6 months
Serum ferritin (SF)
Change in sTfR
Time frame: 6 months
Soluble transferrin receptor (sTfR)
Anemia
Time frame: 6 months
Hb <115 g/L for <12 y; <120 g/L for >=12 y
Iron deficiency (SF)
Time frame: 6 months
Serum ferritin <15.0 µg/L
3 secondary outcomes
Change in TBI
Time frame: 6 months
Iron deficiency (TBI)
Time frame: 6 months
Iron deficiency (sTfr)
Time frame: 6 months
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 19 Feb 2019.
- Derived from this study: PubMed 30759887Finkelstein JL, Mehta S, Villalpando S, Mundo-Rosas V, Luna SV, Rahn M, Shamah-Levy T, Beebe SE, Haas JD. A Randomized Feeding Trial of Iron-Biofortified Beans on School Children in Mexico. Nutrients. 2019 Feb 12;11(2):381. doi: 10.3390/nu11020381.
- Individual participant dataSharing planned: No
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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.
Salvador Villalpando, MD PhD principal investigator
Instituto Nacional de Salud Publica (INSP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron-biofortified beans in people with Iron-deficiency and Anemia, run by Cornell University at 1 site in Mexico.
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 4 inclusion and 2 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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. 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?
Change in hemoglobin (time frame: 6 months). The study lists 5 primary outcomes in all. 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 NCT03835377, which also lists 1 linked publication.
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 19 Feb 2019.