Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02666417
• Date of registration: 20/01/2016
• Prospective Registration: No
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS) FeGOS
• Scientific title: Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa
• Date of first enrolment: January 2016
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02666417
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Kenya

Contacts

• Name: Michael Zimmermann, MD
• Affiliation: Swiss Federal Institute of Technology (ETH), Zurich

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age of 6-14 months at baseline

- Assessment of good health as assessed by professional staff at Msambweni District
Hospital

- Willingness of their caregiver to provide informed consent

Exclusion Criteria:

- Hemoglobin <70 g/L ; these infants will be referred for treatment according to local
standard of care.

- Severe underweight (Z-score weight-for-age <-3) and /or severe wasting (Z-score
weight-for-height<-3)

- Chronic or acute illness or other conditions that in the opinion of the Principle
Investigator (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

- Participants taking part in other studies requiring the drawing of blood

- Participants who are taking iron-containing food supplements or tablets/drops

- Participants who are taking antibiotics



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

Health Condition(s) or Problem(s) studied

Anemia, Iron-Deficiency

Intervention(s)

Dietary Supplement: Fortified maize porridge (MNP+iron+GOS)

Dietary Supplement: Fortified maize porridge (MNP+iron)

Primary Outcome(s)

Change from baseline in the isotopic ratio of iron in blood at week 5 [Time Frame: Baseline and Week 5]

Secondary Outcome(s)

H.pylori [Time Frame: Baseline]

Fecal pH [Time Frame: Baseline and Week 3]

Gut microbiome composition [Time Frame: Baseline and Week 3]

Fecal short chain fatty acids (SCFAs) [Time Frame: Baseline and Week 3]

Secondary ID(s)

FeGOS_KP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Centre for Behavioural Studies

Jomo Kenyatta University of Agriculture and Technology

Msambweni District Hospital