Iron Absorption From Encapsulated Iron Sulphate in Microspheres

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Dietary supplement: free FeSO4; Dietary supplement: free FeSO4 and empty microspheres; Dietary supplement: free FeSO4 and eudragit polymer; Dietary supplement: free FeSO4 and hylauronic acid; Dietary supplement: encapsulated FeSO4 3.2%; Dietary supplement: encapsulated FeSO4 20%; Dietary supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A; Dietary supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid; Dietary supplement: FeSO4 embedded in Hyaluronic acid

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8092
    • Human Nutrition Laboratory, ETH Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: free FeSO4; wheat bread fortified with free FeSO4	Dietary supplement: free FeSO4; Testmeal with free FeSO4
Experimental: free FeSO4 and empty microspheres; wheat bread fortified with free FeSO4, and empty microspheres	Dietary supplement: free FeSO4 and empty microspheres; Testmeal with free FeSO4 and empty micropsheres
Experimental: free FeSO4 with eudragit polymer; wheat bread fortified with free FeSO4, and eudragit polymer	Dietary supplement: free FeSO4 and eudragit polymer; Testmeal with free FeSO4 and eudragit polymer
Experimental: free FeSO4 with Hyaluronic Acid; wheat bread fortified with free FeSO4, and hyaluronic acid	Dietary supplement: free FeSO4 and hylauronic acid; Testmeal with free FeSO4 and hyaluronic acid
Experimental: encapsulated FeSO4 3.2%; wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading	Dietary supplement: encapsulated FeSO4 3.2%; Testmeal with encapsulated FeSO4 with 3.2% Fe loading
Experimental: encapsulated FeSO4 20%; wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading	Dietary supplement: encapsulated FeSO4 20%; Testmeal with encapsulated FeSO4 with 20% Fe loading
Experimental: encapsulated FeSO4 3.2%, encap. Vitamin A; wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres	Dietary supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A; Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A
Experimental: encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid; wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid	Dietary supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid; Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.
Experimental: FeSO4 embedded in Hyaluronic Acid; wheat bread fortified with FeSO4 that is embedded in hyaluronic acid.	Dietary supplement: FeSO4 embedded in Hyaluronic acid; Testmeal with FeSO4 embedded in Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 2 weeks
Change from week 2 in the isotopic ratio of iron in blood at week 4	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.	2 weeks, 4 weeks
Change from week 4 in the isotopic ratio of iron in blood at week 6	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.	4 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin	Haemoglobin of each timepoint	baseline, weeks 2, 4 and 6
Plasma Ferritin	Plasma Ferritin of each timepoint	baseline, weeks 2, 4 and 6
inflammation marker	C reactive Protein of each timepoint	baseline, weeks 2, 4 and 6

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): August 20, 2018

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Iron deficiency; Iron fortification; Iron encapsulation
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Antineoplastic Agents; Immunologic Factors; Protective Agents; Micronutrients; Adjuvants, Immunologic; Antioxidants; Vitamin B Complex; Hematinics; Anticarcinogenic Agents; Viscosupplements; Vitamins; Folic Acid; Hyaluronic Acid; Vitamin A; Fesoterodine; Retinol palmitate
• Other Study ID Numbers: Omnifortificant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No