Effect of Timing of Micronutrient Powder Consumption on Iron Absorption in Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02989311
• Date of registration: 18/10/2016
• Prospective Registration: No
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: Effect of Timing of Micronutrient Powder Consumption on Iron Absorption in Infants
• 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: August 2016
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02989311
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover 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 health professional staff at Msambweni County
Referral 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



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 and Iron)

Dietary Supplement: Fortified Maize porridge (MNP + Iron + GOS)

Primary Outcome(s)

Change from baseline in isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively [Time Frame: Baseline and day 18, baseline and day 19]

Secondary Outcome(s)

Hepcidin concentration [Time Frame: Baseline and day 3, and day 2 for study 1 and 2 respectively]

Iron status [Time Frame: Baseline and days 18 and 19 for study 1 and 2 respectively]

Inflammation status [Time Frame: Baseline and days 18 and 19 for study 1 and 2 respectively]

Secondary ID(s)

FeGOS_Hepcidin

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jomo Kenyatta University of Agriculture and Technology

Msambweni County Referral Hospital