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

NCT ID: NCT02437955

Last Updated: 2015-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

FESO4+T

Ferrous sulfate fortified bread with tea

Group Type: EXPERIMENTAL

Ferrous sulfate fortified bread with tea

Intervention Type: OTHER

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

FESO4+W

Ferrous sulfate fortified bread with water

Group Type: EXPERIMENTAL

ferrous sulfate fortified bread with water

Intervention Type: OTHER

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

FeFu+T

Ferrous fumarate fortified bread with tea

Group Type: EXPERIMENTAL

Ferrous fumarate fortified bread with tea

Intervention Type: OTHER

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

FeFu+W

Ferrous fumarate fortified bread with water

Group Type: EXPERIMENTAL

Ferrous fumarate fortified bread with water

Intervention Type: OTHER

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

Interventions

Ferrous sulfate fortified bread with tea

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

Intervention Type: OTHER

ferrous sulfate fortified bread with water

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

Intervention Type: OTHER

Ferrous fumarate fortified bread with tea

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

Intervention Type: OTHER

Ferrous fumarate fortified bread with water

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Mother and child are willing to participate in the study jointly

Specific inclusions criteria for mothers

• Body weight < 65 kg
• 17 ≤ BMI ≤ 25 (kg/m2)
• Non anemic (Hb ≥ 11,0 g/dl)
• Generally healthy and no chronic illnesses
• Non pregnant
• Non lactating
• No blood donation in the last 4 months
• No consumption of vitamin and nutritional supplements during and 2 weeks prior the study start.

• Age 3-6 years
• Generally healthy and no chronic illnesses
• no consumption of vitamin and mineral supplements during and 2 weeks prior the study start

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ndeye Fatou Ndiaye, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Cheikh Anta Diop de Dakar, Sengal

Locations

Université Cheikh Anta Diop

Dakar, , Senegal

Countries

Senegal

Other Identifiers

EK 2014-N-37

Identifier Type: -

Identifier Source: org_study_id