Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)

Summary

Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. The investigators recently finished a randomized, double blind controlled intervention trial in Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement the intervention study, the present study will compare iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. A stool sample will be collected at baseline and on the first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron absorption from the iron and GOS containing MNP will inform decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still cover the infant requirement for absorbed iron.

Conditions

• Anemia, Iron-Deficiency

Interventions

DIETARY_SUPPLEMENT

Fortified maize porridge (MNP+iron)

Maize porridge will be home-fortified with the MNP + iron. Maize porridge for the test meal will be fortified with labelled iron compounds

DIETARY_SUPPLEMENT

Fortified maize porridge (MNP+iron+GOS)

Maize porridge will be home-fortified with the MNP + iron + GOS. Maize porridge for the test meal will be fortified with labelled iron compounds

Sponsors & Collaborators

• Jomo Kenyatta University of Agriculture and Technology

  collaborator OTHER

• International Centre for Behavioural Studies

  collaborator UNKNOWN

• Msambweni District Hospital

  collaborator UNKNOWN

• Swiss Federal Institute of Technology

  lead OTHER

Principal Investigators

• Michael Zimmermann, MD · Swiss Federal Institute of Technology (ETH), Zurich

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

14 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-04-30

Completion

2016-12-31

Countries

• Kenya

Study Locations