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

NCT ID: NCT01321099

Last Updated: 2012-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-09-30

Brief 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.

Conditions

Iron Deficiency; Anemia

Keywords

Iron absorption; Complementary food fortificant; Young children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

NaFeEDTA

Group Type: EXPERIMENTAL

NaFeEDTA

Intervention Type: OTHER

Labeled iron as FeSO4 or NaFeEDTA added to a test meal

Phatase

Group Type: EXPERIMENTAL

Phytase

Intervention Type: OTHER

Labeled iron as FeSO4 added to a test meal with or without phytase and with or without vitamin C

Vitamin C

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: OTHER

Labeled iron as FeSO4 added to a test meal with or without vitamin C

Interventions

NaFeEDTA

Labeled iron as FeSO4 or NaFeEDTA added to a test meal

Intervention Type: OTHER

Phytase

Labeled iron as FeSO4 added to a test meal with or without phytase and with or without vitamin C

Intervention Type: OTHER

Vitamin C

Labeled iron as FeSO4 added to a test meal with or without vitamin C

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université d'Abomey-Calavi

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Prof. Michael B. Zimmermann

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Hurrell, Prof

Role: PRINCIPAL_INVESTIGATOR

Swiss Federal Institute of Technology (ETH Zürich)

Locations

University of Abomey-Calavi

Cotonou, Cotonou, Benin

Countries

Benin

Other Identifiers

CFF_Fe_Study

Identifier Type: -

Identifier Source: org_study_id