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

This study has been completed.
Sponsor:
Collaborator:
International Foundation for Science (IFS)
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01443832
First received: September 13, 2011
Last updated: October 29, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Iron Deficiency
Dietary Supplement: Fe57 and Fe58-FeSO4 stable isotopes
Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Effect of Dephytinisation of Fonio With Intrinsic Wheat Phytase on Iron Absorption in Beninese Women

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • iron absorption ratio [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    iron isotopes Fe57 and Fe58 concentration in the blood


Biospecimen Retention:   Samples Without DNA

2 samples of 8 ml venous blood per subject


Enrollment: 16
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
iron absorption 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443832

Locations
Benin
Department Nutrition and Food Science/Univsersity of Abomey calavi
Cotonou, Littoral, Benin, 011025
Sponsors and Collaborators
Wageningen University
International Foundation for Science (IFS)
Investigators
Study Director: Inge D Brouwer, Dr Ir Division of Human Nutrition/Wageningen University
  More Information

Publications:
Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01443832     History of Changes
Other Study ID Numbers: 10/12 Fonio Study Benin, 005/CNPERS/SA
Study First Received: September 13, 2011
Last Updated: October 29, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Benin: Comité National Provisoire d'Ethique pour la Recherche en Santé

Keywords provided by Wageningen University:
ferrous sulfate
iron absorption
Beninese women
fonio

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014