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

NCT01053442 | Completed

• 1 other identifier: ETHZ-SIA2
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency

Keywords

iron absorption; stable isotopes; NaFeEDTA; Non-transferrin-bound iron (NTBI); Hepcidin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Isotope incorporation with erythrocytes

  day 22

Study Arms (2)

NaFeEDTA

EXPERIMENTAL

The maize porridge is fortified with 2.5mg iron as NaFeEDTA

Dietary Supplement: Porridge fortified with either NaFeEDTA

FeSO4

ACTIVE COMPARATOR

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

Dietary Supplement: FeSO4

Interventions

Porridge fortified with either NaFeEDTA DIETARY_SUPPLEMENT

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

NaFeEDTA

FeSO4 DIETARY_SUPPLEMENT

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

FeSO4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Serum ferritin \<60 ug/ l, haemoglobin \> 100 g/ l
• Women
• \< 65 kg body weight
• Healthy

You may not qualify if:

• Pregnant or lactating
• Taking iron supplements

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Laboratory of Human Nutrition

Zurich, Canton of Zurich, 08092, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

CH (1)