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

October 29, 2011 updated by: Wageningen University

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Littoral
      • Cotonou, Littoral, Benin, 011025
        • Department Nutrition and Food Science/Univsersity of Abomey calavi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

apparently healthy young women of reproductive age (18-30y)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • iron ferrous sulfate

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Inge D Brouwer, Dr Ir, Division of Human Nutrition/Wageningen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

November 1, 2011

Last Update Submitted That Met QC Criteria

October 29, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

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.

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