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Completed

NCT Number: NCT03332602

Iron Absorption From Encapsulated Iron Sulphate in Microspheres

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

free FeSO4

Dietary Supplement

Testmeal with free FeSO4

free FeSO4 and empty microspheres

Dietary Supplement

Testmeal with free FeSO4 and empty micropsheres

free FeSO4 and hylauronic acid

Dietary Supplement

Testmeal with free FeSO4 and hyaluronic acid

free FeSO4 and eudragit polymer

Dietary Supplement

Testmeal with free FeSO4 and eudragit polymer

encapsulated FeSO4 3.2%

Dietary Supplement

Testmeal with encapsulated FeSO4 with 3.2% Fe loading

encapsulated FeSO4 20%

Dietary Supplement

Testmeal with encapsulated FeSO4 with 20% Fe loading

encapsulated FeSO4 3.2%, encapsulated Vitamin A

Dietary Supplement

Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A

encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid

Dietary Supplement

Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.

FeSO4 embedded in Hyaluronic acid

Dietary Supplement

Testmeal with FeSO4 embedded in Hyaluronic acid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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