NCT02437955

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

Evaluating the National Fortification Policy in Senegal Assessment of Iron Bio-availability in Mother and Child Pairs From Wheat Flour Fortified With Iron With and Without Phenolic Containing Beverages

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: All
• Age: 3 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this study each subject will act as his own control and receive all interventions. Iron absorption data from the different test meals will be therefore compared assessing within and subject effects (main outcomes). Secondary outcomes will also investigate between subject effects and co variates of iron absorption.

Conditions

• Anemia; Deficiency, Nutritional, With Poor Iron Absorption

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2015-05-08
• Last updated: 2015-11-30

Locations

1 site across 1 country: Senegal