Iron Absorption From Complementary Food Fortificants (CFFs) and Acceptability of CFFs by Beninese Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01321099|
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : November 8, 2012
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.
|Condition or disease||Intervention/treatment|
|Iron Deficiency Anemia||Other: NaFeEDTA Other: Phytase Other: Vitamin C|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Study Start Date :||May 2011|
|Primary Completion Date :||June 2012|
|Study Completion Date :||September 2012|
Labeled iron as FeSO4 or NaFeEDTA added to a test meal
Labeled iron as FeSO4 added to a test meal with or without phytase and with or without vitamin C
|Experimental: Vitamin C||
Other: Vitamin C
Labeled iron as FeSO4 added to a test meal with or without vitamin C
- Iron isotope ratio in blood samples [ Time Frame: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study) ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321099
|University of Abomey-Calavi|
|Cotonou, Benin, 562|
|Principal Investigator:||Richard Hurrell, Prof||Swiss Federal Institute of Technology ETH Zürich|