Iron DeficiencyNCT01634932
Iron Absorption From Regular, Biofortified and Post-harvest Fortified Pearl Millet
A study testing Regular iron, Iron biofortified millet and Post-harvest iron-fortifed millet in people with Iron Deficiency and Biofortification, run by Swiss Federal Institute of Technology at 1 site in Benin.
Trial summary
Iron deficiency (ID) with or without anemia is still a main public health problem in sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as children below 5 years of age and women of reproductive age. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Biofortification
- What is being tested?
- Regular iron, Iron biofortified millet and Post-harvest iron-fortifed millet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBenin
- Study dates
- Jul 2012to Sep 2012
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females of reproductive age, 18-30 years
- Low/marginal iron status (Hb > 9.0 g/dl, SF < 25 ;g/L)
- Maximum body weight 65 kg
- Normal body mass index (18.5-25 kg/m2)
- Obtained consent
Who cannot join
- Pregnancy or Lactating (assessed by pregnancy test)
- Fever (body temperature >37.5 °C)
- Symptomatic malaria infection (positive blood smear for Plasmodium species + symptoms)
- Infection with soil-transmitted helminthes (positive stool samples and/or urine samples)
- Intake of mineral/vitamin supplements 2 weeks before and during the study
- Metabolic or gastrointestinal disorders, eating disorders or food allergy
Show all 11Show fewer
- Regular intake of medication
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months
- Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- Former participation in a study involving administration of iron stable isotopes
- Subject who cannot be expected to comply with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Iron Absorption From Regular-iron, Iron Biofortified, and Post-harvest Iron-fortified Pearl Millet Using Multiple Meals in Young Women
Iron deficiency (ID) with or without anemia is still a main public health problem in sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as children below 5 years of age and women of reproductive age. The etiology of ID is multifactorial; but major causes are low iron dietary bioavailability and intake from monotonous cereal-based diets aggravated by chronic parasitic infections such as malaria and soil-transmitted helminthes. Approaches such as dietary diversification, supplementation with pharmacological iron doses, public health measures (e.g. deworming, malaria control) and food fortification with different iron compounds have notably reduced morbidity and mortality caused by ID but have not been universally successful. Biofortification is a new promising approach to combat micronutrient deficiencies such as ID. It is defined as the process of increasing the content and bioavailability of essential nutrients such as iron in crops by traditional plant breeding and/or genetic engineering. Pearl millet is a staple food for many people living in different areas of West Africa (e.g. Northern Benin) and India, two parts of the world, where ID is still widely prevalent. Therefore, pearl millet was one of the crops targeted for iron biofortification by HarvestPlus.
To improve human iron status successfully, the additional iron gained through biofortification has to be at least as bioavailable as the iron in regular peal millet varieties. For that reason we are planning an iron absorption study where we will investigate the iron bioavailability from an iron-biofortified millet variety and compare it with the iron bioavailability from a regular-iron millet variety and from regular-iron millet fortified post-harvest with ferrous sulfate (FeSO4). Iron absorption will be determined by incorporation of labeled iron into erythrocytes, at least 14 days after the administration of the test meals containing labeled iron (stable isotope technique). The three different test meals based on 1) regular-iron, 2) iron-biofortified and 3) post-harvest iron-fortified millet will be administered as multiple meals i.e. each study participant will consume each test meal for a period of 5 days (2 portions/day; one in the morning, one for lunch). Twenty apparently healthy Beninese women with a low/marginal iron status (serum ferritin < 25 ;g/L), non-anemic or mildly anemic (hemoglobin >90 g/L), 18-30 years of age with a body weight < 65 kg and normal body mass index will be included in the study.
The results of the study will provide important insights on the iron bioavailability from regular, biofortified and post-harvest fortified staple crops such as pearl millet when feeding multiple meals as part of a more complex diet. The results can be applied to different meals based on pearl millet such as the West African millet pastes or the Indian flat breads.
- Conditions
- Iron Deficiency, Biofortification
- Being tested
- Regular iron, Iron biofortified millet, Post-harvest iron-fortifed millet
- Keywords
- Iron deficiency, Biofortification, Pearl Millet, Benin
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular ironOther
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
Iron biofortified milletOther
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
Post-harvest iron-fortifed milletOther
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
| Study group | Role | What they receive |
|---|---|---|
| regular-iron millet | Experimental | Not described Receives: Other: Regular iron |
| iron-biofortified millet | Experimental | Not described Receives: Other: Iron biofortified millet |
| Post-harvest iron-fortified millet | Experimental | Not described Receives: Other: Post-harvest iron-fortifed millet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron isotope ratio in blood samples
Whole blood samples will be collected to measure the shift in iron isotope ratios 32 days after administration of isotopic label in the first test meal.
First test meal on study days 1-5, Second test meal on study day 8-12 after a 2-day break, Third (last) test meal on study days 15-19 after a 2-day break, Measurement of iron isotopic shift in blood samples collected on study day 33 (14 days after the last test meal)
Measured: Study day 33 (32 days after administration of isotopic label in the first test meal/End of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Abomey-Calavi
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634932
- Sponsor's protocol ID
- Fe_Biofortified_Millet
- Status last verified
- Nov 2012
- First submitted
- 3 Jul 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Iron Absorption From Regular-iron, Iron Biofortified, and Post-harvest Iron-fortified Pearl Millet Using Multiple Meals in Young Women
- ClinicalTrials.gov ID
- NCT01634932
- Acronym / sponsor ID
- Fe_Biofortified_Millet
- Conditions
- Iron Deficiency, Biofortification
- Keywords
- Iron deficiency, Biofortification, Pearl Millet, Benin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Université d'Abomey-Calavi
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jul 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.
Iron deficiency (ID) with or without anemia is still a main public health problem in sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as children below 5 years of age and women of reproductive age. The etiology of ID is multifactorial; but major causes are low iron dietary bioavailability and intake from monotonous cereal-based diets aggravated by chronic parasitic infections such as malaria and soil-transmitted helminthes. Approaches such as dietary diversification, supplementation with pharmacological iron doses, public health measures (e.g. deworming, malaria control) and food fortification with different iron compounds have notably reduced morbidity and mortality caused by ID but have not been universally successful. Biofortification is a new promising approach to combat micronutrient deficiencies such as ID. It is defined as the process of increasing the content and bioavailability of essential nutrients such as iron in crops by traditional plant breeding and/or genetic engineering. Pearl millet is a staple food for many people living in different areas of West Africa (e.g. Northern Benin) and India, two parts of the world, where ID is still widely prevalent. Therefore, pearl millet was one of the crops targeted for iron biofortification by HarvestPlus.
To improve human iron status successfully, the additional iron gained through biofortification has to be at least as bioavailable as the iron in regular peal millet varieties. For that reason we are planning an iron absorption study where we will investigate the iron bioavailability from an iron-biofortified millet variety and compare it with the iron bioavailability from a regular-iron millet variety and from regular-iron millet fortified post-harvest with ferrous sulfate (FeSO4). Iron absorption will be determined by incorporation of labeled iron into erythrocytes, at least 14 days after the administration of the test meals containing labeled iron (stable isotope technique). The three different test meals based on 1) regular-iron, 2) iron-biofortified and 3) post-harvest iron-fortified millet will be administered as multiple meals i.e. each study participant will consume each test meal for a period of 5 days (2 portions/day; one in the morning, one for lunch). Twenty apparently healthy Beninese women with a low/marginal iron status (serum ferritin < 25 ;g/L), non-anemic or mildly anemic (hemoglobin >90 g/L), 18-30 years of age with a body weight < 65 kg and normal body mass index will be included in the study.
The results of the study will provide important insights on the iron bioavailability from regular, biofortified and post-harvest fortified staple crops such as pearl millet when feeding multiple meals as part of a more complex diet. The results can be applied to different meals based on pearl millet such as the West African millet pastes or the Indian flat breads.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| regular-iron millet | Experimental | Other: Regular iron |
| iron-biofortified millet | Experimental | Other: Iron biofortified millet |
| Post-harvest iron-fortified millet | Experimental | Other: Post-harvest iron-fortifed millet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females of reproductive age, 18-30 years
- Low/marginal iron status (Hb > 9.0 g/dl, SF < 25 ;g/L)
- Maximum body weight 65 kg
- Normal body mass index (18.5-25 kg/m2)
- Obtained consent
Key exclusion criteria (11 listed)
- Pregnancy or Lactating (assessed by pregnancy test)
- Fever (body temperature >37.5 °C)
- Symptomatic malaria infection (positive blood smear for Plasmodium species + symptoms)
- Infection with soil-transmitted helminthes (positive stool samples and/or urine samples)
- Intake of mineral/vitamin supplements 2 weeks before and during the study
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 |
|---|---|---|
| Regular ironLabeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch | Other | regular-iron millet |
| Iron biofortified milletLabeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch | Other | iron-biofortified millet |
| Post-harvest iron-fortifed milletLabeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch | Other | Post-harvest iron-fortified millet |
Primary outcome
Iron isotope ratio in blood samples
Time frame: Study day 33 (32 days after administration of isotopic label in the first test meal/End of the study)
Whole blood samples will be collected to measure the shift in iron isotope ratios 32 days after administration of isotopic label in the first test meal. First test meal on study days 1-5, Second test meal on study day 8-12 after a 2-day break, Third (last) test meal on study days 15-19 after a 2-day break, Measurement of iron isotopic shift in blood samples collected on study day 33 (14 days after the last test meal)
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 8 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular iron, Iron biofortified millet and Post-harvest iron-fortifed millet in people with Iron Deficiency and Biofortification, run by Swiss Federal Institute of Technology at 1 site in Benin.
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 5 inclusion and 11 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 8 Nov 2012. 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 Benin. 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?
Iron isotope ratio in blood samples (time frame: Study day 33 (32 days after administration of isotopic label in the first test meal/End of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2012.