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The Effect of Lactoferrin and Dosing Regimen on Iron Absorption From a Maize-based Porridge in Kenyan Infants

NCT03617575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-05-13

No results posted yet for this study

Summary

The purpose of this study is to measure iron absorption from maize-based porridge fortified with either apo-lactoferrin, holo-lactoferrin or ferrous sulfate and to test whether there is an effect of these. Additionally, iron absorption from maize-based porridge containing 12 mg ferrous sulfate will be measured when consumed every other day versus every third day.

Conditions

  • Iron-deficiency

Interventions

DIETARY_SUPPLEMENT

apo-Lactoferrin

1.41 g of apo-Lactoferrin will be given together with 1.42 mg FeSO4 (0.08 mg of iron naturally in apo-Lf \[total of 1.5 mg iron\]) in a maize porridge (extrinsically labeled)

DIETARY_SUPPLEMENT

holo-Lactoferrin

1.41 g of holo-Lactoferrin (intrinsically labeled with 1.5 mg 57Fe) will be given together in a maize porridge

DIETARY_SUPPLEMENT

FeSO4

1.5 mg FeSO4 as 54Fe in a maize porridge

DIETARY_SUPPLEMENT

1. FeSO4

10 mg 56Fe + 2 mg 54Fe Is the 1. FeSO4 meal in maize porridge

DIETARY_SUPPLEMENT

FeSO4 after 1 day break

10 mg 56Fe + 2 mg 57Fe Is the 2. FeSO4 in maize porridge with a 1 day washout period

DIETARY_SUPPLEMENT

FeSO4 after 2 day break

10 mg 56Fe + 2 mg 58Fe Is the 3. FeSO4 in maize porridge with a 2 day washout period

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
3 Months
Max Age
14 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-03-30
Completion
2019-03-30

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617575 on ClinicalTrials.gov