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

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Deficiency

Treatments: Dietary Supplement: FeSO4; Dietary Supplement: Porridge fortified with either NaFeEDTA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01053442

ETHZ-SIA2

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups

NaFeEDTA

Experimental group

Description:

The maize porridge is fortified with 2.5mg iron as NaFeEDTA

Treatment:

Dietary Supplement: Porridge fortified with either NaFeEDTA

FeSO4

Active Comparator group

Description:

The maize porridge is fortified with 2.5 mg iron as ferrous sulphate plus ascorbic acid.

Treatment:

Dietary Supplement: FeSO4