Iron and Prebiotics Fortification in Kenyan Infants

Summary

Iron deficiency and anemia are health issues affecting mainly infants and women in developing countries. Iron deficiency in infancy can have long-lasting impact on cognitive and motor development of the child. Iron fortification has shown to be effective against anemia. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Therefore we want to assess the effects of home fortification of complementary food with two iron-containing micronutrient powders (MNPs) with and without the addition of a prebiotic (7.5 g of galactooligosaccharides as GOS-75) compared to a control on the composition of the gut microbiota of Kenyan infants. In addition, iron deficiency may iimpair adaptive immunity. Following Kenyan Minstry of Health guidelines, infants receive their first measles vaccine at 9 months. In this study we will use an MNP with a moderate iron dose of 5 mg, with 2.5 mg of Fe as NaFeEDTA and 2.5 mg of Fe as ferrous fumarate (+Fe). There will be 3 study groups MNP, MNP+Fe and MNP+Fe+GOS. The infants will be enrolled in the study at the age of 6-10 months and will consume a home-fortified maize porridge for four months. At baseline and endpoint (after 4 months of intervention), we will collect blood samples of the infants in order to assess anemia, iron status, and inflammation. In addition, we will assess the effect of iron supplementation on measles vaccine response. Fecal samples (from child and mother) will be collected at baseline, 3 weeks and at endpoint in order to evaluate the changes in gut microbiota and gut inflammation.

During the intervention, in a sub-group of children who receive broad-spectrum antibiotics, we will compare how the three different interventions modify the effect of antibiotics on the infant gut microbiota. We will opportunistically select children that are enrolled in the study and who become ill, and who are prescribed antibiotics by the local health care team, according to the local standard of care in the study area. Five additional stool samples from these children will be collected (day 0 (before the first antibiotic dose), 5, 10, 20 and 40) to evaluate the changes in the gut microbiota and gut inflammation.

Three years after the study end, we would like to collect a blood and stool sample from the children and examine the iron status and gut microbiome respectively.

Conditions

• Anemia
• Iron Deficiency
• Diarrhea
• Malaria
• Respiratory Tract Infections (RTI)
• Antibiotics
• Gut Inflammation
• Prebiotics
• Vaccine Response

Interventions

DIETARY_SUPPLEMENT

Fortified maize porridge

Maize porridge will be home-fortified with either A) MNP, B) MNP+Fe, C) MNP+Fe+GOS

Sponsors & Collaborators

• DSM Nutritional Products, Inc.

  collaborator INDUSTRY

• Swiss Federal Institute of Technology

  lead OTHER

Principal Investigators

• Michael Zimmermann, MD · ETH Zurich

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

14 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Kenya

Study Locations