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

NCT01321099 | Completed

• 1 other identifier: CFF_Fe_Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

NaFeEDTA

EXPERIMENTAL

Other: NaFeEDTA

Phatase

EXPERIMENTAL

Other: Phytase

Vitamin C

EXPERIMENTAL

Other: Vitamin C

Interventions

NaFeEDTA OTHER

Labeled iron as FeSO4 or NaFeEDTA added to a test meal

NaFeEDTA

Phytase OTHER

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

Phatase

Vitamin C OTHER

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

Vitamin C

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Université d'Abomey-Calavi: collaborator

Study Sites (1)

University of Abomey-Calavi

Cotonou, Cotonou, 562, Benin

Location

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Interventions

Fe(III)-EDTA; 6-Phytase; Ascorbic Acid

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoric Monoester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Richard Hurrell, Prof

  Swiss Federal Institute of Technology (ETH Zürich)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 8, 2012

Record last verified: 2012-11

Locations

BE (1)