- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01443832
Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study
Effect of Dephytinisation of Fonio With Intrinsic Wheat Phytase on Iron Absorption in Beninese Women
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Littoral
-
Cotonou, Littoral, Benin, 011025
- Department Nutrition and Food Science/Univsersity of Abomey calavi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
iron absorption
|
[57Fe] and [58Fe]- FeSO4 prepared from isotopically enriched 57Fe and 58Fe respectively, by dilution of each compound in 0.1 mol H2SO4/L.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
iron absorption ratio
Time Frame: 14 days
|
iron isotopes Fe57 and Fe58 concentration in the blood
|
14 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Inge D Brouwer, Dr Ir, Division of Human Nutrition/Wageningen University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/12 Fonio Study Benin
- 005/CNPERS/SA (Other Identifier: National Ethical committee (CNPERS-BENIN Republic))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Deficiency
-
Pennington Biomedical Research CenterCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Tampere University HospitalTampere UniversityRecruitingIron Deficiency | Iron Deficiency Anaemia in Childbirth | Iron Status | Iron Deficiency in Pregnancy | Iron Deficiency Anemia in PregnancyFinland
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Children's Hospital Los AngelesNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
Antalya Training and Research HospitalCompletedIron Deficiency Anemia | Iron Deficiency Anemia TreatmentTurkey
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI); Syracuse University; Liverpool... and other collaboratorsCompletedIron-deficiency | Iron-deficiency AnemiaGhana
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
CMH Multan Institute of Medical SciencesCompletedPregnancy | Iron Deficiency Anemia (IDA)Pakistan
-
Ain Shams UniversityActive, not recruitingIron Deficiency Anemia TreatmentEgypt
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
Clinical Trials on Fe57 and Fe58-FeSO4 stable isotopes
-
Swiss Federal Institute of TechnologyAmerican University of Beirut Medical CenterCompleted
-
Ake NorbergNot yet recruiting
-
Swiss Federal Institute of TechnologySwiss Tropical & Public Health Institute; Ifakara Health InstituteCompleted
-
Société des Produits Nestlé (SPN)Completed
-
Baylor College of MedicineCompletedCitrullinemiaUnited States
-
NestléSwiss Federal Institute of Technology; Kamuzu University of Health SciencesCompleted
-
Indiana UniversityASPEN Rhoads Research FoundationTerminatedUlcerative Colitis | Energy Expenditure | Protein MetabolismUnited States
-
Swiss Federal Institute of TechnologyCompletedIron DeficiencySwitzerland
-
Massachusetts General HospitalNational Institutes of Health (NIH)Withdrawn
-
United States Army Institute of Surgical ResearchThe University of Texas Medical Branch, GalvestonCompleted