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

NCT ID: NCT01053442

Last Updated: 2012-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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NaFeEDTA

The maize porridge is fortified with 2.5mg iron as NaFeEDTA

Group Type EXPERIMENTAL

Porridge fortified with either NaFeEDTA

Intervention Type DIETARY_SUPPLEMENT

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

FeSO4

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

Group Type ACTIVE_COMPARATOR

FeSO4

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Porridge fortified with either NaFeEDTA

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

Intervention Type DIETARY_SUPPLEMENT

FeSO4

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laboratory of Human Nutrition

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ETHZ-SIA2

Identifier Type: -

Identifier Source: org_study_id

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