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Iron Absorption From Encapsulated Iron Sulphate in Microspheres

Primary Purpose

Iron-deficiency

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
free FeSO4
free FeSO4 and empty microspheres
free FeSO4 and hylauronic acid
free FeSO4 and eudragit polymer
encapsulated FeSO4 3.2%
encapsulated FeSO4 20%
encapsulated FeSO4 3.2%, encapsulated Vitamin A
encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid
FeSO4 embedded in Hyaluronic acid
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron-deficiency focused on measuring Iron deficiency, Iron fortification, Iron encapsulation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Human Nutrition Laboratory, ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

free FeSO4

free FeSO4 and empty microspheres

free FeSO4 with eudragit polymer

free FeSO4 with Hyaluronic Acid

encapsulated FeSO4 3.2%

encapsulated FeSO4 20%

encapsulated FeSO4 3.2%, encap. Vitamin A

encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid

FeSO4 embedded in Hyaluronic Acid

Arm Description

wheat bread fortified with free FeSO4

wheat bread fortified with free FeSO4, and empty microspheres

wheat bread fortified with free FeSO4, and eudragit polymer

wheat bread fortified with free FeSO4, and hyaluronic acid

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Haemoglobin
Haemoglobin of each timepoint
Plasma Ferritin
Plasma Ferritin of each timepoint
inflammation marker
C reactive Protein of each timepoint

Full Information

First Posted
October 18, 2017
Last Updated
August 30, 2018
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03332602
Brief Title
Iron Absorption From Encapsulated Iron Sulphate in Microspheres
Official Title
The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency
Keywords
Iron deficiency, Iron fortification, Iron encapsulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
free FeSO4
Arm Type
Experimental
Arm Description
wheat bread fortified with free FeSO4
Arm Title
free FeSO4 and empty microspheres
Arm Type
Experimental
Arm Description
wheat bread fortified with free FeSO4, and empty microspheres
Arm Title
free FeSO4 with eudragit polymer
Arm Type
Experimental
Arm Description
wheat bread fortified with free FeSO4, and eudragit polymer
Arm Title
free FeSO4 with Hyaluronic Acid
Arm Type
Experimental
Arm Description
wheat bread fortified with free FeSO4, and hyaluronic acid
Arm Title
encapsulated FeSO4 3.2%
Arm Type
Experimental
Arm Description
wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading
Arm Title
encapsulated FeSO4 20%
Arm Type
Experimental
Arm Description
wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading
Arm Title
encapsulated FeSO4 3.2%, encap. Vitamin A
Arm Type
Experimental
Arm Description
wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres
Arm Title
encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid
Arm Type
Experimental
Arm Description
wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid
Arm Title
FeSO4 embedded in Hyaluronic Acid
Arm Type
Experimental
Arm Description
wheat bread fortified with FeSO4 that is embedded in hyaluronic acid.
Intervention Type
Dietary Supplement
Intervention Name(s)
free FeSO4
Intervention Description
Testmeal with free FeSO4
Intervention Type
Dietary Supplement
Intervention Name(s)
free FeSO4 and empty microspheres
Intervention Description
Testmeal with free FeSO4 and empty micropsheres
Intervention Type
Dietary Supplement
Intervention Name(s)
free FeSO4 and hylauronic acid
Intervention Description
Testmeal with free FeSO4 and hyaluronic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
free FeSO4 and eudragit polymer
Intervention Description
Testmeal with free FeSO4 and eudragit polymer
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4 3.2%
Intervention Description
Testmeal with encapsulated FeSO4 with 3.2% Fe loading
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4 20%
Intervention Description
Testmeal with encapsulated FeSO4 with 20% Fe loading
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4 3.2%, encapsulated Vitamin A
Intervention Description
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid
Intervention Description
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.
Intervention Type
Dietary Supplement
Intervention Name(s)
FeSO4 embedded in Hyaluronic acid
Intervention Description
Testmeal with FeSO4 embedded in Hyaluronic acid
Primary Outcome Measure Information:
Title
Change from baseline in the isotopic ratio of iron in blood at week 2
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
baseline, 2 weeks
Title
Change from week 2 in the isotopic ratio of iron in blood at week 4
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
2 weeks, 4 weeks
Title
Change from week 4 in the isotopic ratio of iron in blood at week 6
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
4 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
Haemoglobin
Description
Haemoglobin of each timepoint
Time Frame
baseline, weeks 2, 4 and 6
Title
Plasma Ferritin
Description
Plasma Ferritin of each timepoint
Time Frame
baseline, weeks 2, 4 and 6
Title
inflammation marker
Description
C reactive Protein of each timepoint
Time Frame
baseline, weeks 2, 4 and 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Human Nutrition Laboratory, ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

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Iron Absorption From Encapsulated Iron Sulphate in Microspheres

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