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

NCT ID: NCT01443832

Last Updated: 2011-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-02-28

Brief 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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

iron absorption

Fe57 and Fe58-FeSO4 stable isotopes

Intervention Type: DIETARY_SUPPLEMENT

\[57Fe\] and \[58Fe\]- FeSO4 prepared from isotopically enriched 57Fe and 58Fe respectively, by dilution of each compound in 0.1 mol H2SO4/L.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

iron ferrous sulfate

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

International Foundation for Science (IFS)

OTHER

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inge D Brouwer, Dr Ir

Role: STUDY_DIRECTOR

Division of Human Nutrition/Wageningen University

Locations

Department Nutrition and Food Science/Univsersity of Abomey calavi

Cotonou, Littoral Department, Benin

Countries

Benin

References

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.

Reference Type: BACKGROUND

PMID: 16522911 (View on PubMed)

Other Identifiers

005/CNPERS/SA

Identifier Type: OTHER

Identifier Source: secondary_id

10/12 Fonio Study Benin

Identifier Type: -

Identifier Source: org_study_id