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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02437955
• Date of registration: 15/04/2015
• Prospective Registration: No
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: Fe Absorption in Mother and Child Pairs From Wheat Fortified With Iron With and Without Phenolic Containing Beverages Fe_Senegal
• Scientific 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
• Date of first enrolment: April 2015
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02437955
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Senegal

Contacts

• Name: Ndeye Fatou Ndiaye, PhD
• Affiliation: Université Cheikh Anta Diop de Dakar, Sengal

Key inclusion & exclusion 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



Age minimum: 3 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia; Deficiency, Nutritional, With Poor Iron Absorption

Intervention(s)

Other: Ferrous sulfate fortified bread with tea

Other: Ferrous fumarate fortified bread with water

Other: ferrous sulfate fortified bread with water

Other: Ferrous fumarate fortified bread with tea

Primary Outcome(s)

Iron absorption measured as iron incorporation of stable isotopic labels in red blood cells 14 days after administration [Time Frame: Up to 8 Months after study start]

Secondary Outcome(s)

Correlation between iron absorption in mother and child pairs [Time Frame: Up to 8 Months after study start]

Secondary ID(s)

EK 2014-N-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cheikh Anta Diop University, Senegal