Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study

Iron Deficiency Clinical Trial

Official title:

Effect of Dephytinisation of Fonio With Intrinsic Wheat Phytase on Iron Absorption in Beninese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443832
• Other study ID #: 10/12 Fonio Study Benin
• Secondary ID: 005/CNPERS/SA
• Status: Completed
• Phase: Phase 0
• First received: September 13, 2011
• Last updated: October 29, 2011
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: October 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Benin: Comité National Provisoire d'Ethique pour la Recherche en Santé
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

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.

Locations

Country	Name	City	State
Benin	Department Nutrition and Food Science/Univsersity of Abomey calavi	Cotonou	Littoral

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	International Foundation for Science (IFS)

Country where clinical trial is conducted

Benin, 

References & Publications (1)

Moretti D, Zimmermann MB, Wegmüller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iron absorption ratio	iron isotopes Fe57 and Fe58 concentration in the blood	14 days	No