Iron DeficiencyNCT01443832
Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study
An observational study of Iron Deficiency, run by Wageningen University at 1 site in Benin.
Trial summary
The study sought to investigate the effect of lowering phytic acid in fonio porridge with phytase activity naturally occurring in wheat flour on iron absorption using labelled stable isotopes of iron. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Fe57 and Fe58-FeSO4 stable isotopes
- How many people
- 16 participants
- Where
- 1 siteBenin
- Study dates
- Sep 2010to Feb 2011
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: apparently healthy young women of reproductive age (18-30y)
Who may be able to join
- age 18 - 30 y-old
- apparently healthy
- body weight < 65 kg (confirmed by anthropometric measurement at recruitment)
- not pregnant (confirmed by pregnancy test)
- not lactating (confirmed by age of last child if any)
- no reported chronic medical illnesses (diabetes, rheumatism, high blood pressure, etc)
Show all 12Show fewer
- no reported symptoms of malaria in the last 2 months (fever, headache, stomachache, diarrhoea, nausea, vomiting) (confirmed by malaria test)
- No severe anemia (Hb<90 g/l)
- no intake of vitamin and mineral supplements in the last 2 weeks
- no iron medication or supplementation during the study
- no blood donation in the last 6 months
- no reported allergy to gluten
Who cannot join
- body weight (> 65 kg)
- pregnant
- recent fever malaria
- abnormal CRP level (>10 mg/l)
- severe anemia (Hb < 90g/l) and iron deficiency (serum ferritin concentration < 12 µg/l)
Trial locations and contacts
1 site in 1 country.
Benin1 site
Department Nutrition and Food Science/Univsersity of Abomey calavi
Cotonou, Littoral Department, 011025
About this study
Official title: Effect of Dephytinisation of Fonio With Intrinsic Wheat Phytase on Iron Absorption in Beninese Women
The study sought to investigate the effect of lowering phytic acid in fonio porridge with phytase activity naturally occurring in wheat flour on iron absorption using labelled stable isotopes of iron. The study population is represented by 16 apparently healthy young Beninese women aged 18-30 years recruited based on their willingness to participate and according to inclusion criteria. Test meals consisted of fonio porridges fortified with isotopically labelled [57Fe] or [58Fe] ferrous sulfate with and without wheat flour. Meals were administered to fasting subjects on two consecutive days using a randomised crossover design: half the subjects received the test meal on the first day and the control on the second day and vice versa. Venous blood sample were collected (day 1 and day 14) for iron status and iron absorption measurement. Iron absorption measurement is based on erythrocyte incorporation of iron stable isotope labels 14 days after intake of the labelled test meals and calculated based on isotope-dilution.
Read the detailed description
Objective: To compare the bioavailability of iron in fonio porridge fortified with isotopically enriched [57Fe] or [58Fe]-ferrous sulfate with and without reducing phytic acid by native phytase in wheat flour.
Study population: Sixteen apparently healthy young women aged 18-30 years recruited at the University based on their willingness to participate and according to inclusion criteria.
Study design: Fonio porridges fortified with isotopically labelled [57Fe] or [58Fe] ferrous sulfate, with (test meal) and without wheat flour (control meal) are administered to fasting subjects on two consecutive days using a randomised crossover design. Half the subjects received the test meal on the first day and the control on the second day and vice versa. No food or drink was allowed within the 3 hours after consumption. All meals were administered under close supervision. Venous blood sample were collected (day 1 and day 16) for iron status and iron absorption measurement. Iron absorption measurement is calculated based on iron isotope-dilution in erythrocyte 14 days after intake of the labelled meals.
Study parameters: Fourteen days before the test, height and weight were measured for nutritional status and subjects were screened for pregnancy and malaria. They were also treated with antihelminth (albendazole tablet). The day before meals test (day 0), whole blood sample was collected for hemoglobin (Hb), serum ferritin (SF), serum Transferrin Receptor (sTfR) and C-reactive protein (CRP). Anemia and iron deficiency was defined as Hb < 120 g/L, and SF < 12 µg/L respectively. Pregnancy test and malaria tests were repeated on that day. On day 1 and day 2, the fonio porridges were randomly given to the subjects on a cross-over designed. Fourteen days after the meal test (day 16) whole blood sample was collected for iron absorption measurement.
- Conditions
- Iron Deficiency
- Being tested
- Fe57 and Fe58-FeSO4 stable isotopes
- Keywords
- ferrous sulfate, iron absorption, Beninese women, fonio
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fe57 and Fe58-FeSO4 stable isotopesDietary supplement
Also called iron ferrous sulfate
[57Fe] and [58Fe]- FeSO4 prepared from isotopically enriched 57Fe and 58Fe respectively, by dilution of each compound in 0.1 mol H2SO4/L.
| Study group | Role | What they receive |
|---|---|---|
| iron absorption | Not described Receives: Dietary Supplement: Fe57 and Fe58-FeSO4 stable isotopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron absorption ratio
iron isotopes Fe57 and Fe58 concentration in the blood
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionFeb 2011
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- International Foundation for Science (IFS)
- Responsible party
- Sponsor
- Investigators
- Inge D Brouwer, Dr Ir, Study director, Division of Human Nutrition/Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443832
- Sponsor's protocol ID
- 10/12 Fonio Study Benin
- Other IDs
- 005/CNPERS/SA
- Status last verified
- Oct 2011
- First submitted
- 13 Sep 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Moretti D, Zimmermann MB, Wegmuller R, Walczyk T, Zeder C, Hurrell RF. Iron status and food matrix strongly affect the relative bioavailability of ferric pyrophosphate in humans. Am J Clin Nutr. 2006 Mar;83(3):632-8. doi: 10.1093/ajcn.83.3.632.
PubMed 16522911
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dephytinisation of Fonio With Intrinsic Wheat Phytase on Iron Absorption in Beninese Women
- ClinicalTrials.gov ID
- NCT01443832
- Acronym / sponsor ID
- 10/12 Fonio Study Benin
- Conditions
- Iron Deficiency
- Keywords
- ferrous sulfate, iron absorption, Beninese women, fonio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- International Foundation for Science (IFS)
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Sep 2011 (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 study sought to investigate the effect of lowering phytic acid in fonio porridge with phytase activity naturally occurring in wheat flour on iron absorption using labelled stable isotopes of iron. The study population is represented by 16 apparently healthy young Beninese women aged 18-30 years recruited based on their willingness to participate and according to inclusion criteria. Test meals consisted of fonio porridges fortified with isotopically labelled [57Fe] or [58Fe] ferrous sulfate with and without wheat flour. Meals were administered to fasting subjects on two consecutive days using a randomised crossover design: half the subjects received the test meal on the first day and the control on the second day and vice versa. Venous blood sample were collected (day 1 and day 14) for iron status and iron absorption measurement. Iron absorption measurement is based on erythrocyte incorporation of iron stable isotope labels 14 days after intake of the labelled test meals and calculated based on isotope-dilution.
Detailed description
Objective: To compare the bioavailability of iron in fonio porridge fortified with isotopically enriched [57Fe] or [58Fe]-ferrous sulfate with and without reducing phytic acid by native phytase in wheat flour.
Study population: Sixteen apparently healthy young women aged 18-30 years recruited at the University based on their willingness to participate and according to inclusion criteria.
Study design: Fonio porridges fortified with isotopically labelled [57Fe] or [58Fe] ferrous sulfate, with (test meal) and without wheat flour (control meal) are administered to fasting subjects on two consecutive days using a randomised crossover design. Half the subjects received the test meal on the first day and the control on the second day and vice versa. No food or drink was allowed within the 3 hours after consumption. All meals were administered under close supervision. Venous blood sample were collected (day 1 and day 16) for iron status and iron absorption measurement. Iron absorption measurement is calculated based on iron isotope-dilution in erythrocyte 14 days after intake of the labelled meals.
Study parameters: Fourteen days before the test, height and weight were measured for nutritional status and subjects were screened for pregnancy and malaria. They were also treated with antihelminth (albendazole tablet). The day before meals test (day 0), whole blood sample was collected for hemoglobin (Hb), serum ferritin (SF), serum Transferrin Receptor (sTfR) and C-reactive protein (CRP). Anemia and iron deficiency was defined as Hb < 120 g/L, and SF < 12 µg/L respectively. Pregnancy test and malaria tests were repeated on that day. On day 1 and day 2, the fonio porridges were randomly given to the subjects on a cross-over designed. Fourteen days after the meal test (day 16) whole blood sample was collected for iron absorption measurement.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iron absorption | – | Dietary Supplement: Fe57 and Fe58-FeSO4 stable isotopes |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- apparently healthy young women of reproductive age (18-30y)
Key inclusion criteria (12 listed)
- age 18 - 30 y-old
- apparently healthy
- body weight < 65 kg (confirmed by anthropometric measurement at recruitment)
- not pregnant (confirmed by pregnancy test)
- not lactating (confirmed by age of last child if any)
Key exclusion criteria (5 listed)
- body weight (> 65 kg)
- pregnant
- recent fever malaria
- abnormal CRP level (>10 mg/l)
- severe anemia (Hb < 90g/l) and iron deficiency (serum ferritin concentration < 12 µg/l)
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 |
|---|---|---|
| Fe57 and Fe58-FeSO4 stable isotopesAlso: iron ferrous sulfate[57Fe] and [58Fe]- FeSO4 prepared from isotopically enriched 57Fe and 58Fe respectively, by dilution of each compound in 0.1 mol H2SO4/L. | Dietary supplement | iron absorption |
Primary outcome
iron absorption ratio
Time frame: 14 days
iron isotopes Fe57 and Fe58 concentration in the blood
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 1 Nov 2011.
- Background: PubMed 16522911Moretti D, Zimmermann MB, Wegmuller R, Walczyk T, Zeder C, Hurrell RF. Iron status and food matrix strongly affect the relative bioavailability of ferric pyrophosphate in humans. Am J Clin Nutr. 2006 Mar;83(3):632-8. doi: 10.1093/ajcn.83.3.632.
Related trials for Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
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.
Inge D Brouwer, Dr Ir study director
Division of Human Nutrition/Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency, run by Wageningen University 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 12 inclusion and 5 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 1 Nov 2011. 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 absorption ratio (time frame: 14 days). 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 NCT01443832, 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 1 Nov 2011.