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

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01053442
First received: January 20, 2010
Last updated: April 4, 2012
Last verified: April 2012
  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 Blind (Subject)
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 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' ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Isotope incorporation with erythrocytes [ Time Frame: day 22 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01053442

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

No publications provided

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
Study First Received: January 20, 2010
Last Updated: April 4, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014