Iron Bioavailability From Encapsulated Ferrous Sulphate

Study Overview
=================
Brief Summary
-----------------
Salt is one of the very few regularly purchased food item in all socioeconomic classes including poor remote areas with subsistence farming. Therefore, it is a promising vehicle for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour change in fortified salt without significantly compromise bioavailability. In the present project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family (EPO).

Official Title
-----------------
Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket

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

Intervention / Treatment
-----------------
* Dietary Supplement: non-encapsulated FeSO4
* Dietary Supplement: encapsulated FeSO4, before cooking
* Dietary Supplement: encapsulated FeSO4, after cooking
* Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid
* Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking
* Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 18 to 40 years old Marginal iron status (ferritin < 25 ng/ml) Body weight < 65 kg Normal body Mass Index (18.5 - 25 kg/m2) Signed informed consent Exclusion Criteria: Pregnancy (assessed by a pregnancy test) / intention to become pregnant Lactating up to 6 weeks before study initiation Moderate or severe anaemia (hemoglobin < 9.0 g/dL) Elevated C-reactive protein (> 5.0 mg/L) Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) Continuous/long-term use of medication during the whole study (except for contraceptives) Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: non-encapsulated FeSO4<br>Maize porridge with salt fortified with non-encapsulated FeSO4 | Dietary Supplement: non-encapsulated FeSO4<br> <br> |
| Experimental: encapsulated FeSO4, before cooking<br>Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking | Dietary Supplement: encapsulated FeSO4, before cooking<br> <br> |
| Experimental: encapsulated FeSO4, after cooking<br>Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking | Dietary Supplement: encapsulated FeSO4, after cooking<br> <br> |
| Experimental: non-encapsulated FeSO4 + ascorbic acid<br>Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid | Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid<br> <br> |
| Experimental: encapsulated FeSO4 + ascorbic acid, before cooking<br>Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking | Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking<br> <br> |
| Experimental: encapsulated FeSO4 + ascorbic acid, after cooking<br>Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking | Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the isotopic ratio of iron in blood at week 2 | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. | baseline, 2 weeks | 
| Change from week 2 in the isotopic ratio of iron in blood at week 4 | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. | 2 weeks, 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency, Iron fortification, Iron encapsulation