Iron Bioavailability From Encapsulated Ferrous Sulphate

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02353325

Enrollment

Registered

2015-02-02

Start date

2016-03-31

Completion date

2016-06-30

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Keywords

Iron deficiency, Iron fortification, Iron encapsulation

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).

Interventions

DIETARY_SUPPLEMENTnon-encapsulated FeSO4

DIETARY_SUPPLEMENTencapsulated FeSO4, before cooking

DIETARY_SUPPLEMENTencapsulated FeSO4, after cooking

DIETARY_SUPPLEMENTnon-encapsulated FeSO4 + ascorbic acid

DIETARY_SUPPLEMENTencapsulated FeSO4 + ascorbic acid, before cooking

DIETARY_SUPPLEMENTencapsulated FeSO4 + ascorbic acid, after cooking

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026