NCT01443832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

4 months

First QC Date

September 13, 2011

Last Update Submit

October 29, 2011

Conditions

Iron Deficiency

Keywords

ferrous sulfateiron absorptionBeninese womenfonio

Outcome Measures

Primary Outcomes (1)

  • iron absorption ratio

    iron isotopes Fe57 and Fe58 concentration in the blood

    14 days

Study Arms (1)

iron absorption

Dietary Supplement: Fe57 and Fe58-FeSO4 stable isotopes

Interventions

Fe57 and Fe58-FeSO4 stable isotopesDIETARY_SUPPLEMENT

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

Also known as: iron ferrous sulfate
iron absorption

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Nutrition and Food Science/Univsersity of Abomey calavi

Cotonou, Littoral Department, 011025, Benin

Location

Related Publications (1)

  • 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.

    PMID: 16522911BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 samples of 8 ml venous blood per subject

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Inge D Brouwer, Dr Ir

    Division of Human Nutrition/Wageningen University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 30, 2011

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

BE(1)