Clinical Trials Directory

Trials / Completed

CompletedNCT01053442

Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate

Absorption, Stable Isotope Appearance and NTBI Profile From NaFeEDTA and Ferrous Sulphate

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
17 (actual)
Sponsor
Swiss Federal Institute of Technology · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA. The absorption profile of these may differ because of differences in their dissolution in the gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption. As these differences might lead result in varying reactions in the blood stream, the appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total iron in the plasma will be monitored over six hours in adult women. This is relevant as a spike of absorbed iron may increase non-transferrin-bound iron and this could be pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption and will help explain the potential differences in the plasma iron profile. The use of stable iron isotope appearance curves to specifically detect the appearance of small amounts of absorbed iron in the blood and distinguish between circulating body iron and iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now used in a bigger sample to test the differences in absorption profile of ferrous sulphate, FePPi and NaFeEDTA given at fortification level with a meal.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPorridge fortified with either NaFeEDTA265g maize porridge is fortified with 2.5 mg iron as NaFeEDTA.
DIETARY_SUPPLEMENTFeSO4Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid.

Timeline

Start date
2010-01-01
Primary completion
2010-03-01
Completion
2010-03-01
First posted
2010-01-21
Last updated
2012-04-05

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01053442. Inclusion in this directory is not an endorsement.