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

NCT02437955 | Completed

• 1 other identifier: EK 2014-N-37
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Deficiency, Nutritional, With Poor Iron Absorption

Outcome Measures

Primary Outcomes (1)

• Iron absorption measured as iron incorporation of stable isotopic labels in red blood cells 14 days after administration

  The effect of the consumption of tea (phenolic containing beverages) will be assessed the two iron fortification compounds. The interaction between beverage and compound on iron absorption will be tested. The analysis will be separately conducted for mothers and children.

  Up to 8 Months after study start

Secondary Outcomes (1)

• Correlation between iron absorption in mother and child pairs

  Up to 8 Months after study start

Study Arms (4)

FESO4+T

EXPERIMENTAL

Ferrous sulfate fortified bread with tea

Other: Ferrous sulfate fortified bread with tea

FESO4+W

EXPERIMENTAL

Ferrous sulfate fortified bread with water

Other: ferrous sulfate fortified bread with water

FeFu+T

EXPERIMENTAL

Ferrous fumarate fortified bread with tea

Other: Ferrous fumarate fortified bread with tea

FeFu+W

EXPERIMENTAL

Ferrous fumarate fortified bread with water

Other: Ferrous fumarate fortified bread with water

Interventions

Ferrous sulfate fortified bread with tea OTHER

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

FESO4+T

ferrous sulfate fortified bread with water OTHER

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

FESO4+W

Ferrous fumarate fortified bread with tea OTHER

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

FeFu+T

Ferrous fumarate fortified bread with water OTHER

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

FeFu+W

Eligibility Criteria

• Age: 3 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mother and child are willing to participate in the study jointly
• Body weight \< 65 kg
• ≤ 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Cheikh Anta Diop University, Senegal: collaborator

Study Sites (1)

Université Cheikh Anta Diop

Dakar, Senegal

Location

MeSH Terms

Conditions

Anemia

Interventions

Tea; Water

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Ndeye Fatou Ndiaye, PhD

  Université Cheikh Anta Diop de Dakar, Sengal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

SE (1)