Fe Absorption in Mother and Child Pairs From Wheat Fortified With Iron With and Without Phenolic Containing Beverages
- Conditions
- Anemia; Deficiency, Nutritional, With Poor Iron Absorption
- Interventions
- Other: Ferrous sulfate fortified bread with teaOther: Ferrous fumarate fortified bread with teaOther: ferrous sulfate fortified bread with waterOther: Ferrous fumarate fortified bread with water
- Registration Number
- NCT02437955
- Lead Sponsor
- Swiss Federal Institute of Technology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description FESO4+T Ferrous sulfate fortified bread with tea Ferrous sulfate fortified bread with tea FeFu+T Ferrous fumarate fortified bread with tea Ferrous fumarate fortified bread with tea FESO4+W ferrous sulfate fortified bread with water Ferrous sulfate fortified bread with water FeFu+W Ferrous fumarate fortified bread with water Ferrous fumarate fortified bread with water
- Primary Outcome Measures
Name Time Method Iron absorption measured as iron incorporation of stable isotopic labels in red blood cells 14 days after administration Up to 8 Months after study start 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.
- Secondary Outcome Measures
Name Time Method Correlation between iron absorption in mother and child pairs Up to 8 Months after study start The correlation of iron absorption from the different test meals between in mother and child pairs will be assessed. A variable will be defined which will consist of the difference in iron absorption between each mother and child, within one mother child pair cluster. Determinants of this variable will be explored by linear regression, such as iron status, parity, age, gender, anthropometry, iron status, vitamin status (A, B2, B12, folate) h. pylori test and hepcidin.
Trial Locations
- Locations (1)
Université Cheikh Anta Diop
🇸🇳Dakar, Senegal
Université Cheikh Anta Diop🇸🇳Dakar, Senegal