Iron Bioavailability From Encapsulated Ferrous Sulphate

Swiss Federal Institute of Technology20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Iron Deficiency

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: baseline, 2 weeks

Change from week 2 in the isotopic ratio of iron in blood at week 4