- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053442
Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate (SIA)
Absorption, Stable Isotope Appearance and NTBI Profile From NaFeEDTA and Ferrous Sulphate
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, 08092
- Laboratory of Human Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NaFeEDTA
The maize porridge is fortified with 2.5mg iron as 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.
|
Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stable iron isotope appearance in the plasma over 8 hours
Time Frame: day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480'
|
day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480'
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Isotope incorporation with erythrocytes
Time Frame: day 22
|
day 22
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETHZ-SIA2
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