Trials / Completed
CompletedNCT01053442
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Swiss Federal Institute of Technology · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Porridge fortified with either NaFeEDTA | 265g maize porridge is fortified with 2.5 mg iron as NaFeEDTA. |
| DIETARY_SUPPLEMENT | FeSO4 | Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid. |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2010-01-21
- Last updated
- 2012-04-05
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01053442. Inclusion in this directory is not an endorsement.