Fe Absorption in Mother and Child Pairs From Wheat Fortified With Iron With and Without Phenolic Containing Beverages

NCT02437955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-11-30

No results posted yet for this study

Summary

In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50 months indicating that iron deficiency is a major health problem. The government of Senegal has implemented a flour fortification program including iron and folate. Iron is a difficult mineral to add to foods efficiently due to its organoleptic properties and typical low bioavailability in man. The aim of this study is to determine iron absorption from fortified wheat flour consumed with a phenolic containing beverage in women and child pairs. The fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly investigated.

The bioavailability of the different iron compounds will be determined using stable iron isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women between 18-45y) will be selected for participation in the study. After a screening, each women and child will receive 4 test meals consisting of a bread roll fortified stable isotopes with and without the tisane beverage. The first two test meals will be consumed on consecutive days. Two weeks after the second test meal a blood sample will be taken from each women and child before the third meal administration. After the forth test meal administration, and again two weeks later, the last blood sampling will take place and the study will be conducted for the subjects (duration 30 days). The samples will be sent to Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as well as inflammation status (CRP) will be determined.

Conditions

  • Anemia; Deficiency, Nutritional, With Poor Iron Absorption

Interventions

OTHER

Ferrous sulfate fortified bread with tea

Fasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes

OTHER

ferrous sulfate fortified bread with water

Fasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes

OTHER

Ferrous fumarate fortified bread with tea

Fasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes

OTHER

Ferrous fumarate fortified bread with water

Fasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes

Sponsors & Collaborators

  • Cheikh Anta Diop University, Senegal

    collaborator OTHER
  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Ndeye Fatou Ndiaye, PhD · Université Cheikh Anta Diop de Dakar, Sengal

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-06-30
Completion
2015-10-31

Countries

  • Senegal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02437955 on ClinicalTrials.gov