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Iron Absorption From Encapsulated Iron Sulphate in Microspheres

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ClinicalTrials.gov Identifier: NCT03332602
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Iron-deficiency Dietary Supplement: free FeSO4 Dietary Supplement: free FeSO4 and empty microspheres Dietary Supplement: free FeSO4 and hylauronic acid Dietary Supplement: free FeSO4 and eudragit polymer 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
Actual Study Start Date : April 4, 2018
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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




Primary Outcome Measures :
  1. Change from baseline in the isotopic ratio of iron in blood at week 2 [ Time Frame: baseline, 2 weeks ]
    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  2. Change from week 2 in the isotopic ratio of iron in blood at week 4 [ Time Frame: 2 weeks, 4 weeks ]
    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  3. Change from week 4 in the isotopic ratio of iron in blood at week 6 [ Time Frame: 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 :
  1. Haemoglobin [ Time Frame: baseline, weeks 2, 4 and 6 ]
    Haemoglobin of each timepoint

  2. Plasma Ferritin [ Time Frame: baseline, weeks 2, 4 and 6 ]
    Plasma Ferritin of each timepoint

  3. inflammation marker [ Time Frame: baseline, weeks 2, 4 and 6 ]
    C reactive Protein of each timepoint



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332602


Locations
Switzerland
Human Nutrition Laboratory, ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology

Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT03332602     History of Changes
Other Study ID Numbers: Omnifortificant
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Federal Institute of Technology:
Iron deficiency
Iron fortification
Iron encapsulation

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamins
Folic Acid
Vitamin A
Iron
Vitamin B Complex
Hyaluronic Acid
Retinol palmitate
Fesoterodine
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Hematinics
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Antineoplastic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents