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

Study Overview
=================
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.

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

Conditions
-----------------
Iron Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Porridge fortified with either NaFeEDTA
* Dietary Supplement: FeSO4


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaFeEDTA<br>The maize porridge is fortified with 2.5mg iron as NaFeEDTA | Dietary Supplement: Porridge fortified with either NaFeEDTA<br>* 265g maize porridge is fortified with 2.5 mg iron as NaFeEDTA.<br>|
| Active Comparator: FeSO4<br>The maize porridge is fortified with 2.5 mg iron as ferrous sulphate plus ascorbic acid. | Dietary Supplement: FeSO4<br>* Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isotope incorporation with erythrocytes |  | day 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron absorption, stable isotopes, NaFeEDTA, Non-transferrin-bound iron (NTBI), Hepcidin