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

NCT02989311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-10-06

No results posted yet for this study

Summary

Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA by ensuring that the iron needs of infants and young children are met without changing their traditional diet. In order to optimize iron absorption timing of MNP consumption might as well be important. This is because hepcidin, a key regulator of systemic iron balance, shows a circadian increase that may influence morning versus afternoon iron absorption from the MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit iron absorption from a second dose, consumed close in time to the first dose.

To determine the difference between i) morning versus afternoon iron absorption and ii) consecutive versus alternate day iron absorption, investigators will enrol 20 infants from Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days and 1 alternate day. In both studies, fourteen days after the last test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. Hepcidin concentrations will be measured before the morning and afternoon meals (study 1) and after second consecutive meal (study 2).

Knowing the effect of time on the expected iron absorption will inform decisions on the ideal timing of MNP to cover the infant's requirement for absorbed iron.

Conditions

Interventions

DIETARY_SUPPLEMENT

Fortified maize porridge (MNP and Iron)

Maize porridge fortified with MNP and labelled iron compound

DIETARY_SUPPLEMENT

Fortified Maize porridge (MNP + Iron + GOS)

Maize porridge fortified with MNP + GOS and labelled iron compound

Sponsors & Collaborators

  • Jomo Kenyatta University of Agriculture and Technology

    collaborator OTHER
  • Msambweni County Referral Hospital

    collaborator UNKNOWN
  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Michael Zimmermann, MD · Swiss Federal Institute of Technology (ETH), Zurich

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

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 NCT02989311 on ClinicalTrials.gov