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Completed

NCT Number: NCT01053442

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Human Nutrition

Zurich, Canton of Zurich, 08092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Porridge fortified with either NaFeEDTA

Dietary Supplement

265g maize porridge is fortified with 2.5 mg iron as NaFeEDTA.

FeSO4

Dietary Supplement

Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid.

Primary outcomes

  1. 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'

Secondary outcomes

  1. Isotope incorporation with erythrocytes

    Time frame: day 22

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

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

Acronym: SIA

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2010
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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