Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate (SIA)
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|ClinicalTrials.gov Identifier: NCT01053442|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : April 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency||Dietary Supplement: Porridge fortified with either NaFeEDTA Dietary Supplement: FeSO4||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Absorption, Stable Isotope Appearance and NTBI Profile From NaFeEDTA and Ferrous Sulphate|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
The maize porridge is fortified with 2.5mg iron as NaFeEDTA
Dietary Supplement: Porridge fortified with either NaFeEDTA
265g maize porridge is fortified with 2.5 mg iron as NaFeEDTA.
Active Comparator: FeSO4
The maize porridge is fortified with 2.5 mg iron as ferrous sulphate plus ascorbic acid.
Dietary Supplement: FeSO4
Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid.
- Stable iron isotope appearance in the plasma over 8 hours [ Time Frame: day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480' ]
- Isotope incorporation with erythrocytes [ Time Frame: day 22 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053442
|Laboratory of Human Nutrition|
|Zurich, Switzerland, 08092|