Iron and Prebiotics Fortification in Kenyan Infants (Iro'n'Pre)
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ClinicalTrials.gov Identifier: NCT02118402 |
Recruitment Status :
Completed
First Posted : April 21, 2014
Last Update Posted : February 5, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
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Anemia Iron Deficiency Diarrhea Malaria Respiratory Tract Infections (RTI) Antibiotics Gut Inflammation Prebiotics Vaccine Response | Dietary Supplement: Fortified maize porridge | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 155 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | In Home Iron Fortification in Kenyan Infants: Effect of Co-supplementation With Galactooligosaccharides (GOS) on the Gut Microbiota Composition and the Effectiveness of Iron Supplementation |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
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Active Comparator: Fortified maize porridge (MNP)
The MNP contains 400 µg Vitamin A, 5 µg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 µg Folic Acid, 6 mg Niacin, 0.9 µg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 µg Iodine, 17 µg Selenium, 4.1 mg Zinc, 190 Phytase-units, maltodextrin carrier (added up to 11g)
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Dietary Supplement: Fortified maize porridge
Maize porridge will be home-fortified with either A) MNP, B) MNP+Fe, C) MNP+Fe+GOS |
Active Comparator: Fortified maize porridge (MNP+Fe)
The MNP contains 400 µg Vitamin A, 5 µg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 µg Folic Acid, 6 mg Niacin, 0.9 µg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 µg Iodine, 17 µg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as ferrous fumarate and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g)
|
Dietary Supplement: Fortified maize porridge
Maize porridge will be home-fortified with either A) MNP, B) MNP+Fe, C) MNP+Fe+GOS |
Active Comparator: Fortified maize porridge (MNP+Fe+GOS)
The MNP contains 400 µg Vitamin A, 5 µg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 µg Folic Acid, 6 mg Niacin, 0.9 µg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 µg Iodine, 17 µg Selenium, 4.1 mg Zinc, 190 Phytase-units, 2.5 mg Fe as ferrous fumarate and 2.5 mg Fe as NaFeEDTA plus 7.5 g of galactooligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g)
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Dietary Supplement: Fortified maize porridge
Maize porridge will be home-fortified with either A) MNP, B) MNP+Fe, C) MNP+Fe+GOS |
- The co-primary outcomes are the gut microbiome and gut inflammation [ Time Frame: Change from baseline to 3 weeks and 16 weeks ]We will measure key commensal and pathogenic members of the fecal gut microbiota of the infants using qPCR and 16S rDNA sequencing. We will measure fecal calprotectin and serum intestinal fatty acid binding protein as markers of gut inflammation and enterocyte injury. The changes in these measurements during the intervention will be compared among the three groups.
- Iron status and systemic inflammation [ Time Frame: Change from baseline to endpoint (16 weeks) ]We will assess serum ferritin, soluble transferrin receptor, erythrocyte zinc protoporphyrin and hemoglobin to define the iron status. C-reactive protein to assess systemic inflammatory status. The changes in these measurements during the intervention will be compared among the three groups.
- Anthropometry [ Time Frame: Change from baseline to endpoint (16 weeks) ]Anthropometric data (weight, height, age and sex) will be recorded using standardized procedures to calculate the prevalence of child stunting. Measurements will be conducted at the start of the intervention and after 4 months (end point). The data analysis software WHO Anthro (WHO, Geneva Switzerland) will be used to calculate the prevalence of stunting among this infant population. The changes in these measurements during the intervention will be compared among the three groups.
- Child to -mother transmission of gut microbiota [ Time Frame: Change from baseline to 3 weeks and endpoint (16 weeks) ]We will measure key commensal and pathogenic members of the fecal gut microbiota of the mothers using qPCR and pyrosequencing. We will measure fecal calprotectin and serum and fecal zonulin as markers of gut inflammation. The changes in these measurements during the intervention will be compared among the three groups of mothers, and correlations will be done to assess associations of the variables within the mother-child pairs.
- Gut microbiota and gut inflammation during and after an oral antibiotic treatment [ Time Frame: Change from baseline day 0 (prior to antibiotic administration) to day 5, 10, 20 and 40 ]We will measure key commensal and pathogenic members of the fecal gut microbiota of the infants using qPCR and pyrosequencing. We will measure fecal calprotectin and serum and fecal zonulin as markers of gut inflammation. The changes in these measurements during and after an oral antibiotic treatment will be assessed and compared between the three groups.
- Morbidity [ Time Frame: Weekly assessment from baseline to endpoint (16 weeks) ]Morbidity data (fever, cough, diarrhea, bloody and mucous stool) will be assessed weekly with a questionnaire. The frequency of these morbidities during the intervention will be compared among the three groups.
- Human milk oligosaccharides in breast milk [ Time Frame: Sampling time points at week 3 and week 16 ]Breast milk from n=90 mothers will be analyzed to quantify human milk oligosaccharides concentration.
- Long term gut microbiota composition [ Time Frame: Change from endpoint to 3 years after study end ]We will measure key commensal and pathogenic members of the fecal gut microbiota of the infants using qPCR and pyrosequencing. We will measure fecal calprotectin and fecal zonulin as markers of gut inflammation. The changes in these measurements compared to endpoint will be assessed and compared between the three intervention groups
- Long term iron status and systemic inflammation [ Time Frame: Change from endpoint to 3 years after study end ]We will assess serum ferritin, soluble transferrin receptor and hemoglobin to define the iron status. Using C-reactive protein and alpha-1-acid glycoprotein we will assess inflammatory status. The changes in these measurements during the intervention will be compared among the three groups.
- Primary vaccine response [ Time Frame: anti-measels serum IgG and avidity at age 12months (endpoint intervention) ]We will determine anti-measles serum IgG and IgG avidity to assess vaccine response
- Secondary vaccine response [ Time Frame: anti-measels serum IgG and avidity at 3 years after study end ]We will determine anti-measles serum IgG and IgG avidity to assess vaccine response

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Ages Eligible for Study: | 6 Months to 14 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age of 6-10 months at baseline
- Assessment of good health as assessed by professional staff at Kikoneni Health Clinic.
- Willingness of their caregiver to provide informed consent
Exclusion Criteria:
- Hemoglobin <7g/dL; these participants will be referred for treatment at the local health clinic according to the guidelines of Kenya Ministry of Health.
- Participants taking part in other studies requiring the drawing of blood.
- Chronic or acute illness or other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.
- Not planning long-term residence in study site
- Participants who are taking iron-containing food supplements or tablets/drops.

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): NCT02118402
Kenya | |
Kikoneni Health Center | |
Kikoneni, Kwale County, Kenya |
Principal Investigator: | Michael Zimmermann, MD | ETH Zurich |
Responsible Party: | Swiss Federal Institute of Technology |
ClinicalTrials.gov Identifier: | NCT02118402 |
Other Study ID Numbers: |
DSM-2-70790-11 |
First Posted: | April 21, 2014 Key Record Dates |
Last Update Posted: | February 5, 2020 |
Last Verified: | February 2020 |
Respiratory Tract Infections Inflammation Diarrhea Pathologic Processes |
Infections Signs and Symptoms, Digestive Respiratory Tract Diseases |