Completed

The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.

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What is being tested

free FeSO4

+ free FeSO4 and empty microspheres

+ free FeSO4 and hylauronic acid

Dietary Supplement
Who is being recruted

Iron Deficiencies+6

+ Anemia

+ Anemia, Hypochromic

From 18 to 40 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: April 2018
See protocol details

Summary

Principal SponsorSwiss Federal Institute of Technology
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 4, 2018

Actual date on which the first participant was enrolled.

Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes. Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.

Official TitleThe Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
NCT03332602
Principal SponsorSwiss Federal Institute of Technology
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iron DeficienciesAnemiaAnemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, Iron-DeficiencyIron Metabolism Disorders

Criteria

5 inclusion criteria required to participate
Female, 18 to 40 years old

Marginal iron status (PF <25 ng/ml)

Body weight < 65 kg

Normal body Mass Index (18.5 - 25 kg/m2)

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10 exclusion criteria prevent from participating
Pregnancy (assessed by a pregnancy test) / intention to become pregnant

Lactating up to 6 weeks before study initiation

Moderate or severe anaemia (Hb < 9.0 g/dL)

Elevated C reactive Protein (CRP) (> 5.0 mg/L)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

9 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
wheat bread fortified with free FeSO4

Group II

Experimental
wheat bread fortified with free FeSO4, and empty microspheres

Group III

Experimental
wheat bread fortified with free FeSO4, and hyaluronic acid

Group IV

Experimental
wheat bread fortified with free FeSO4, and eudragit polymer

Group 5

Experimental
wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading

Group 6

Experimental
wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading

Group 7

Experimental
wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres

Group 8

Experimental
wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid

Group 9

Experimental
wheat bread fortified with FeSO4 that is embedded in hyaluronic acid.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Human Nutrition Laboratory, ETH Zurich

Zurich, SwitzerlandOpen Human Nutrition Laboratory, ETH Zurich in Google Maps
CompletedOne Study Center