Iron Absorption From Complementary Food Fortificants (CFFs) and Acceptability of CFFs by Beninese Children

Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321099
• Other study ID #: CFF_Fe_Study
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: November 7, 2012
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Iron deficiency (ID) is still a main public health problem in sub-Saharan Africa. Iron deficient children have an increased risk for anemia which is associated with adverse infant development that might be partly irreversible. In sub-Saharan Africa, the etiology of ID in children is multifactoral; but the major causes are low iron dietary bioavailability and intake from monotonous cereal-based complementary foods. Children < 5 years old can benefit from iron-fortified complementary foods; however, these fortified complementary foods are often not adapted to the requirements of children in specific setting. The investigators developed a complementary food fortificant (CFF) which is added to local porridge and is deemed to meet the nutrient intake requirement for iron in children 1-3 years of age. The CFF is lipid-based and can therefore, if regularly used, increase the daily energy intake of children which is often too low in developing countries with cereal-based diets.

The iron absorption from the mixture of CFF and porridge has to be optimized because it contains quite a high amount of phytate, a well-known inhibitor of iron absorption. To optimize iron absorption the investigators are planning three iron absorption studies using different compounds of iron (FeSO4 + NaFeEDTA), additional vitamin C and phytase, which is able to degrade phytate. In the first study, iron absorption will be determined from a mixture of CFF and porridge fortified with 1) 6 mg FeSO4 and 2) 6 mg FeSO4 plus additional vitamin C. In the second study, the test meals will be fortified with 1) 6 mg FeSO4 and 2) a mixture of 3 mg FeSO4 + 3 mg NaFeEDTA. In the third study, test meals will be fortified with 1) 6 mg FeSO4, 2) 6 mg FeSO4 plus phytase, and 3) 6 mg FeSO4 plus additional vitamin C and phytase. Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable isotope technique). Sixty apparently healthy Beninese children 12-36 months of age with a body weight > 8.3 kg will be included in the study. Additionally, the investigators will test acceptability of CFFs based on different composition formulas by interviewing the parents/legal guardians of the children after feeding the CFF for a defined period.

The results of these studies will provide important insights to optimize the iron absorption of young children from a CFF mixed with local traditional porridge in developing countries. Furthermore the studies will provide information on the acceptability of CFFs in such a setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 36 Months

Eligibility

Inclusion Criteria:

• Female or male children, 12 - 36 months of age

• A body weight of at least 8.3 kg; weight for age = -3 Z-score

• No malaria parasites in the blood smear + negative malaria rapid test

• No hematuria

• No intake of mineral/vitamin supplements 2 weeks before and during the study

• No metabolic or gastrointestinal disorders

Exclusion Criteria:

• Fever (body temperature > 37.5 °C)

• Severe anemia (hemoglobin < 8.0 g/dl)

• Regular intake of medication

• Blood transfusion or significant blood loss (accident, surgery) over the past 4 months

• Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study

• Former participation in a study involving administration of iron stable isotopes

• Subject who cannot be expected to comply with study protocol

• Eating disorders or food allergy

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• NaFeEDTA
Labeled iron as FeSO4 or NaFeEDTA added to a test meal
• Phytase
Labeled iron as FeSO4 added to a test meal with or without phytase and with or without vitamin C
• Vitamin C
Labeled iron as FeSO4 added to a test meal with or without vitamin C

Locations

Country	Name	City	State
Benin	University of Abomey-Calavi	Cotonou

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Université d'Abomey-Calavi

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron isotope ratio in blood samples	Whole blood samples will be collected to measure the shift in iron isotope ratios 16 days after administration of isotopic label in the first test meal.; First test meal on study day 1, Second test meal on study day 2, Third (last) test meal on study day 3, Measurement of iron isotopic shift in blood samples collected on study day 17	Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)	No