Iron and Prebiotics Fortification in Kenyan Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02118402
• Date of registration: 10/04/2014
• Prospective Registration: Yes
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: Iron and Prebiotics Fortification in Kenyan Infants Iro'n'Pre
• Scientific 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
• Date of first enrolment: July 2014
• Target sample size: 155
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02118402
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Kenya

Contacts

• Name: Michael Zimmermann, MD
• Affiliation: ETH Zurich

Key inclusion & exclusion 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.



Age minimum: 6 Months
Age maximum: 14 Months
Gender: All

Health Condition(s) or Problem(s) studied

Antibiotics

Respiratory Tract Infections (RTI)

Diarrhea

Malaria

Vaccine Response

Anemia

Iron Deficiency

Gut Inflammation

Prebiotics

Intervention(s)

Dietary Supplement: Fortified maize porridge

Primary Outcome(s)

The co-primary outcomes are the gut microbiome and gut inflammation [Time Frame: Change from baseline to 3 weeks and 16 weeks]

Secondary Outcome(s)

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]

Anthropometry [Time Frame: Change from baseline to endpoint (16 weeks)]

Iron status and systemic inflammation [Time Frame: Change from baseline to endpoint (16 weeks)]

Child to -mother transmission of gut microbiota [Time Frame: Change from baseline to 3 weeks and endpoint (16 weeks)]

Morbidity [Time Frame: Weekly assessment from baseline to endpoint (16 weeks)]

Secondary ID(s)

DSM-2-70790-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DSM Nutritional Products, Inc.