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

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT01053442

Collaborator

DSM Nutritional Products, Inc. (Industry)

Enrollment

Location

Arms

1.9

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Iron Deficiency	Dietary Supplement: Porridge fortified with either NaFeEDTA Dietary Supplement: FeSO4	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Stable iron isotope appearance in the plasma over 8 hours [day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480']

Secondary Outcome Measures

Isotope incorporation with erythrocytes [day 22]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Human Nutrition	Zurich		Switzerland	08092

Sponsors and Collaborators

Swiss Federal Institute of Technology
DSM Nutritional Products, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT01053442

Other Study ID Numbers:

ETHZ-SIA2

First Posted:

Jan 21, 2010

Last Update Posted:

Apr 5, 2012

Last Verified:

Apr 1, 2012

Keywords provided by Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology

iron absorption

stable isotopes

NaFeEDTA

Non-transferrin-bound iron (NTBI)

Hepcidin

Additional relevant MeSH terms:

Anemia, Iron-Deficiency

Fe(III)-EDTA

Study Results

No Results Posted as of Apr 5, 2012