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

Not Applicable

Completed

• Conditions: Iron Deficiency
• Interventions: Dietary Supplement: Porridge fortified with either NaFeEDTA; Dietary Supplement: FeSO4

• Registration Number: NCT01053442
• Lead Sponsor: Swiss Federal Institute of Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Serum ferritin <60 ug/ l, haemoglobin > 100 g/ l
• Women
• < 65 kg body weight
• Healthy

Exclusion Criteria

• Pregnant or lactating
• Taking iron supplements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NaFeEDTA	Porridge fortified with either NaFeEDTA	The maize porridge is fortified with 2.5mg iron as NaFeEDTA
FeSO4	FeSO4	The maize porridge is fortified with 2.5 mg iron as ferrous sulphate plus ascorbic acid.

Primary Outcome Measures

Name	Time	Method
Stable iron isotope appearance in the plasma over 8 hours	day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480'

Secondary Outcome Measures

Name	Time	Method
Isotope incorporation with erythrocytes	day 22

Trial Locations

Locations (1)

Laboratory of Human Nutrition; 🇨🇭 Zurich, Switzerland