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

Absorption, Stable Isotope Appearance and NTBI Profile From NaFeEDTA and Ferrous Sulphate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01053442
Acronym
SIA
Enrollment
17
Registered
2010-01-21
Start date
2010-01-31
Completion date
2010-03-31
Last updated
2012-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTPorridge fortified with either NaFeEDTA

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

DIETARY_SUPPLEMENTFeSO4

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

Sponsors

DSM Nutritional Products, Inc.
CollaboratorINDUSTRY
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Stable iron isotope appearance in the plasma over 8 hoursday 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480'

Secondary

MeasureTime frame
Isotope incorporation with erythrocytesday 22

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026