Iron Absorption From Encapsulated Iron Sulphate in Microspheres

Not Applicable

Completed

• Conditions: Iron-deficiency
• Interventions: Dietary Supplement: free FeSO4 and empty microspheres; Dietary Supplement: free FeSO4 and hylauronic acid; Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A; Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid; Dietary Supplement: free FeSO4 and eudragit polymer; Dietary Supplement: encapsulated FeSO4 20%; Dietary Supplement: FeSO4 embedded in Hyaluronic acid; Dietary Supplement: free FeSO4; Dietary Supplement: encapsulated FeSO4 3.2%

• Registration Number: NCT03332602
• Lead Sponsor: Swiss Federal Institute of Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2018-04-04
• Primary Completion: 2018-07-18
• Status Verified: 2018-08
• Study Completion: 2018-08-20
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• 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)
• 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 (Hb < 9.0 g/dL)
• Elevated C reactive Protein (CRP) (> 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
free FeSO4 and empty microspheres	free FeSO4 and empty microspheres	wheat bread fortified with free FeSO4, and empty microspheres
free FeSO4 with Hyaluronic Acid	free FeSO4 and hylauronic acid	wheat bread fortified with free FeSO4, and hyaluronic acid
encapsulated FeSO4 3.2%, encap. Vitamin A	encapsulated FeSO4 3.2%, encapsulated Vitamin A	wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres
encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid	encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid	wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid
free FeSO4 with eudragit polymer	free FeSO4 and eudragit polymer	wheat bread fortified with free FeSO4, and eudragit polymer
encapsulated FeSO4 20%	encapsulated FeSO4 20%	wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading
FeSO4 embedded in Hyaluronic Acid	FeSO4 embedded in Hyaluronic acid	wheat bread fortified with FeSO4 that is embedded in hyaluronic acid.
free FeSO4	free FeSO4	wheat bread fortified with free FeSO4
encapsulated FeSO4 3.2%	encapsulated FeSO4 3.2%	wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading

Primary Outcome Measures

Name	Time	Method
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.
Change from week 4 in the isotopic ratio of iron in blood at week 6	4 weeks, 6 weeks	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Secondary Outcome Measures

Name	Time	Method
Plasma Ferritin	baseline, weeks 2, 4 and 6	Plasma Ferritin of each timepoint
Haemoglobin	baseline, weeks 2, 4 and 6	Haemoglobin of each timepoint
inflammation marker	baseline, weeks 2, 4 and 6	C reactive Protein of each timepoint

Trial Locations

Locations (1)

Human Nutrition Laboratory, ETH Zurich; 🇨🇭 Zurich, Switzerland