Iron and Prebiotics Fortification in Kenyan Infants (Iro'n'Pre)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Swiss Federal Institute of Technology
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT02118402
First received: April 10, 2014
Last updated: June 17, 2015
Last verified: June 2015
  Purpose

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 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. 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.


Condition Intervention
Anemia
Iron Deficiency
Diarrhea
Malaria
Respiratory Tract Infections (RTI)
Antibiotics
Gut Inflammation
Prebiotics
Dietary Supplement: Fortified maize porridge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • The co-primary outcomes are the gut microbiome and gut inflammation [ Time Frame: Change from baseline to 3 weeks and 16 weeks ] [ Designated as safety issue: No ]
    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 the intervention will be compared among the three groups.


Secondary Outcome Measures:
  • Iron status and systemic inflammation [ Time Frame: Change from baseline to endpoint (16 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Human milk oligosaccharides in breast milk [ Time Frame: Sampling time points at week 3 and week 16 ] [ Designated as safety issue: No ]
    Breast milk from n=20 mothers will be analyzed to quantify human milk oligosaccharides concentration.


Estimated Enrollment: 150
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
Dietary Supplement: Fortified maize porridge
Maize porridge will be home-fortified with either A) MNP, B) MNP+Fe, C) MNP+Fe+GOS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118402

Contacts
Contact: Tanja Barth-Jaeggi, PhD tanja.barth@hest.ethz.ch
Contact: Diego Moretti, PhD diego.moretti@hest.ethz.ch

Locations
Kenya
Kikoneni Health Center Recruiting
Kikoneni, Kwale County, Kenya
Contact: Francis Katana       franciskmwangome@yahoo.com   
Principal Investigator: Penny Holding, PhD         
Sponsors and Collaborators
Swiss Federal Institute of Technology
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Diego Moretti, PhD University of Zurich
Study Director: Tanja Barth-Jaeggi, PhD University of Zurich
  More Information

No publications provided

Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02118402     History of Changes
Other Study ID Numbers: DSM-2-70790-11
Study First Received: April 10, 2014
Last Updated: June 17, 2015
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Inflammation
Respiratory Tract Infections
Anemia
Anemia, Hypochromic
Hematologic Diseases
Infection
Iron Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 03, 2015