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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053442
First Posted: January 21, 2010
Last Update Posted: April 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
  Purpose

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 Intervention
Iron Deficiency Dietary Supplement: Porridge fortified with either NaFeEDTA Dietary Supplement: FeSO4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Absorption, Stable Isotope Appearance and NTBI Profile From NaFeEDTA and Ferrous Sulphate

Resource links provided by NLM:


Further study details as provided by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Isotope incorporation with erythrocytes [ Time Frame: day 22 ]

Enrollment: 17
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NaFeEDTA
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Switzerland
Laboratory of Human Nutrition
Zurich, Switzerland, 08092
Sponsors and Collaborators
Swiss Federal Institute of Technology
DSM Nutritional Products, Inc.
  More Information

Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01053442     History of Changes
Other Study ID Numbers: ETHZ-SIA2
First Submitted: January 20, 2010
First Posted: January 21, 2010
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology:
iron absorption
stable isotopes
NaFeEDTA
Non-transferrin-bound iron (NTBI)
Hepcidin

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Fe(III)-EDTA
Edetic Acid
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Hematinics