NCT01321099

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	NaFeEDTA	Labeled iron as FeSO4 or NaFeEDTA added to a test meal
OTHER	Phytase	Labeled iron as FeSO4 added to a test meal with or without phytase and with or without vitamin C
OTHER	Vitamin C	Labeled iron as FeSO4 added to a test meal with or without vitamin C

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-06-01
• Completion: 2012-09-01
• First posted: 2011-03-23
• Last updated: 2012-11-08

Locations

1 site across 1 country: Benin