Clinical trial NCT02353325: Iron Bioavailability From Encapsulated Ferrous Sulphate
Official title: Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: Iron deficiency
Iron fortification
Iron encapsulation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).


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)

Primary outcomes:
measure: Change from baseline in the isotopic ratio of iron in blood at week 2
timeFrame: baseline, 2 weeks
measure: Change from week 2 in the isotopic ratio of iron in blood at week 4
timeFrame: 2 weeks, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Human Nutrition Laboratory, ETH Zurich
Study officials:
References: