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

April 4, 2012 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Absorption, Stable Isotope Appearance and 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 08092
        • Laboratory of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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'
day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480'

Secondary Outcome Measures

Outcome Measure
Time Frame
Isotope incorporation with erythrocytes
Time Frame: day 22
day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

DSM Nutritional Products, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (ESTIMATE)

January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETHZ-SIA2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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