Clinical trial NCT02437955: Fe Absorption in Mother and Child Pairs From Wheat Fortified With Iron With and Without Phenolic Containing Beverages
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia; Deficiency, Nutritional, With Poor Iron Absorption
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Cheikh Anta Diop University, Senegal
First posted: 2015-05-08
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Inclusion criteria for children:

* 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

Primary outcomes:
measure: Iron absorption measured as iron incorporation of stable isotopic labels in red blood cells 14 days after administration
timeFrame: Up to 8 Months after study start
Secondary outcomes:
measure: Correlation between iron absorption in mother and child pairs
timeFrame: Up to 8 Months after study start
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Université Cheikh Anta Diop
Study officials:
affiliation: Université Cheikh Anta Diop de Dakar, Sengal
name: Ndeye Fatou Ndiaye, PhD
role: PRINCIPAL_INVESTIGATOR
References: