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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 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: April 16, 2014
Last verified: April 2014
  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 (galactooligosaccharides, GOS) 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 (5 mg, 2.5 mg NaFeEDTA and 2.5 mg ferrous fumarate). 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), we will collect blood samples of the infants in order to assess anemia, iron status, and inflammation. fecal samples will be collected at baseline, 3 weeks and at endpoint in order to evaluate the changes in gut microbiota and gut inflammation.


Condition Intervention
Anemia
Iron Deficiency
Diarrhea
Malaria
Respiratory Tract Infections (RTI)
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:
  • Gut microbiome and inflammation [ Time Frame: Change from baseline to 3 weeks and 16 weeks ] [ Designated as safety issue: No ]
    We will measure important commensal and pathogenic members of the fecal gut microbiota of the infants using 16S rRNA qPCR and pyrosequencing. Then the changes over the intervention and the differences in the groups will be compared. The same will be done with fecal calprotectin an gut inflammation marker.


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, zinc protoporphyrin to heme ratio and hemoglobin to define the iron status and its change over the intervention in the 3 groups. Systemic inflammation will be measured with C-reactive protein and acute-phase protein.

  • 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.


Estimated Enrollment: 150
Study Start Date: July 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 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
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 ferrous fumarate and 2.5 mg NaFeEDTA
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 ferrous fumarate and 2.5 mg NaFeEDTA plus 7.5 g of galactooligosaccharides
Dietary Supplement: Fortified maize porridge
Maize porridge will be home-fortified with either A) MNP, B) MNP+Fe, C) MNP+Fe+GOS

Detailed Description:

Fifty infants per group will be enrolled (n=150) and randomLy divided in three groups, from those identified in selected villages in the catchment area of the Kikoneni Health Clinic in southern coastal Kenya, about 2 hours south of Mombasa. All children of whose parents agree to participate in the study will have their iron status assessed (Hemoglobin, ZPP, Serum ferritin and soluble serum transferrin receptor). Enrolled subjects will be randomized into three groups, stratified for iron status (Hemoglobin and Zinc Protoporphyrin), and will receive four types of identical sachets (color matched) containing all a mixture of micronutrients. For group 1 will receive the MNP alone, group 2 will receive an identical MNP with iron (2.5 mg Fe as NaFeEDTA and 2.5 mg ferrous fumarate), and group 3 will get the MNP with iron (2.5 mg Fe as NaFeEDTA and 2.5 mg ferrous fumarate) and 7.5 mg of galactooligosaccharides (GOS). Each household will receive 2 kg of maize meal per week and the mothers of the participating children will be shown how to prepare the food at home and will be engaged in discussions regarding childcare. These micronutrient powders will be added by the parents to finely-ground maize meal porridge, the locally used complementary food. This maize meal will be provided free-of-charge to all participating families Kikoneni Clinic will serve as the collection point for the micronutrient powder, the monitoring center for surveillance of infant health, as well as the blood and stool collection point.

At baseline, and at endpoint of the intervention (4 months), a blood sample will be collected the measurement of hemoglobin (Hb). To define anemia; serum ferritin (SF), C-reactive protein (CRP) and zinc protoporphyrin (ZPP) will be measured to assess iron status. Two baseline stool samples will be collected for determination of colonic microbiota. At the weekly visits to the health center during the study, the mother will bring in their infant's stool sample of the same day, where it will be labeled and kept in a fridge. The mothers will be trained to collect the stool samples at home in a provided container with a tight, screw-top lid, that includes an Anerocult® sachet to create an anaerobic environment. The samples will be transferred to the lab in Msambweni, filled in 2 ml Eppendorf tubes, labelled and frozen at - 20°C.

In addition compliance and morbidity will be assessed weekly during the distribution of the MNPs. The children will be checked and referred to the health center clinicians whenever indicated by the clinical history. In the case of fever, a rapid malaria test (RTD) kit will be performed according to local guidelines. If the test results positive, the child will be treated for presumptive malaria, mild malaria cases will be treated at Kikoneni clinic as per WHO Integrated management of childhood illness (IMCI) guidelines. Cases of diarrhea will be treated with oral rehydration solution (ORS). If deemed necessary by the Kikoneni clinical management, the study team will support the clinic in re stocking ORS, iron supplements and antimalaric drugs for the study duration.

Anthropometry (weight, height, age and sex) will be recorded at baseline and endpoint using standardized procedures to calculate the prevalence of child stunting. The measurements will be done twice and the average used for data analysis. The data analysis software WHO Anthro (WHO, Geneva Switzerland) will be used to calculate the prevalence of stunting among this infant population.

  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 Jaeggi, MSc tanja.jaeggi@hest.ethz.ch
Contact: Diego Moretti, PhD diego.moretti@hest.ethz.ch

Locations
Kenya
Kikoneni Health Center Not yet 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 ETH Zurich
Study Director: Tanja Jaeggi, MSc ETH 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: April 16, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Anemia
Diarrhea
Malaria
Respiratory Tract Infections
Anemia, Iron-Deficiency
Hematologic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
Infection
Respiratory Tract Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 18, 2014