Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study
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|ClinicalTrials.gov Identifier: NCT01443832|
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : November 1, 2011
|Condition or disease||Intervention/treatment|
|Iron Deficiency||Dietary Supplement: Fe57 and Fe58-FeSO4 stable isotopes|
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 :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Effect of Dephytinisation of Fonio With Intrinsic Wheat Phytase on Iron Absorption in Beninese Women|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2011|
Dietary Supplement: Fe57 and Fe58-FeSO4 stable isotopes
[57Fe] and [58Fe]- FeSO4 prepared from isotopically enriched 57Fe and 58Fe respectively, by dilution of each compound in 0.1 mol H2SO4/L.
Other Name: iron ferrous sulfate
- iron absorption ratio [ Time Frame: 14 days ]iron isotopes Fe57 and Fe58 concentration in the blood
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443832
|Department Nutrition and Food Science/Univsersity of Abomey calavi|
|Cotonou, Littoral, Benin, 011025|
|Study Director:||Inge D Brouwer, Dr Ir||Division of Human Nutrition/Wageningen University|