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Completed

NCT Number: NCT03895424

Iron Isotope Study of an Iron Fatty Acid Complex

The study aims at assessing the iron (Fe) bioavailability from a newly developed iron compound - an iron fatty acid complex. The iron from the compound is hypothesized to have a higher absorption rate than commonly available supplements in the market. The study is a cross over, human iron isotope study with three arms where participants consume the experimental dietary products in a randomized fashion. The study duration is of 45 days - from the day of the capsule administration till the last blood sampling point

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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

Lab of Human Nutrition, ETH Zurich

Zurich, Canton of Zurich, 8092, Switzerland

About this study

Iron deficiency remains a major public health concern in both industrialized and non-industrialized (developing) countries. Most supplements in the present day, to address the problem of iron deficiency, are in the form of ferrous salts, especially ferrous sulfate. Ferrous salts are absorbed by the non-heme iron pathway involving the Divalent Metal Transporter 1 (DMT-1) receptor, where the absorption rate is 20% of the total iron content. The common strategy of the food supplement industries is to increase the iron load in the supplements to provide the necessary amount of iron, compensating for the low absorption rate. However, these have side effects associated with the high dosage. Instead of a high dosage, a more effective strategy would be to incorporate the iron in a way that the absorption rate is maximized. The intervention product, an iron fatty acid complex (IFAC), containing 12 mg of iron, is expected to be absorbed as effective as any ferrous sulfate supplement in the market due to the alternative metabolic route that is hypothesized to be taken by the complex.

The first week of the study comprises of the administration of the capsules containing the complexes to the participants on day 1 , day 3 and day 5 of the study respectively. Blood samples are collected on day 10,20, 30 and 40 and 160 days after the last day of the capsule administration..

The primary objectives of this trial are:

To assess the iron bioavailability from the developed iron salt fatty acid complexes (IFAC) and micro-emulsified iron fatty acid complex (MIFAC) and compare it with the bioavailability of the reference ferrous sulfate (FeSO4) To investigate whether the MIFAC promotes absorption compared to IFAC and the reference.

Fractional iron absorption from the three intervention products will be calculated based on the shift of the stable iron isotope ratios in collected blood samples at 10, 20, 30, 40 and 160 days after administration of the stable isotopically labelled capsules. Stable iron isotope ratios will be determined by mass spectrometry.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age of 18 - 40 years old
  • marginal iron status (ferritin <25 ng/ml; measured by study coordinator)
  • body weight up to 65 kg
  • normal body mass index (bodyweight [kg] / (height [m])2 = 18.5 - 25)
  • do not take any vitamin or mineral supplements two weeks before and during the study.
  • do not have a metabolic, gastrointestinal or chronic diseases
  • able to communicate in and comprehend English language

Exclusion criteria

  • pregnant or breast-feeding
  • on long-term medication (except oral contraceptive)
  • elevated C-reactive Protein (>5mg/L; will be measured by study coordinator)
  • medium or strong anemic (hemoglobin <9.0 g/dL; will be measured by study coordinator)
  • donated blood within the last 4 months before the study start date
  • taking part in another clinical study at the same time or had within the last 30 days before the study date
  • participated in an earlier study using iron stable isotopes.
  • eating disorder or a strong allergy.
  • cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
  • unable to understand the information sheet and the informed consent form due to cognitive or language reasons

Treatment and study plan

IFAC

Dietary Supplement

This intervention will contain the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope 58Fe

MIFAC

Dietary Supplement

This intervention will contain the micellarized form of the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope with 57Fe

Control Ferrous Sulfate

Dietary Supplement

This intervention will contain ferrous sulfate in the form of a solution labelled with the iron isotope 54Fe. A capsule with the same amount of fat as in the other arms will be administered to the participants

Primary outcomes

  1. Fractional iron absorption from IFAC

    Time frame: Day 10 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  2. Fractional iron absorption from IFAC

    Time frame: Day 20 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  3. Fractional iron absorption from IFAC

    Time frame: Day 30 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  4. Fractional iron absorption from IFAC

    Time frame: Day 40 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  5. Fractional iron absorption from IFAC

    Time frame: Day 160 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  6. Fractional iron absorption from MIFAC

    Time frame: Day 10 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  7. Fractional iron absorption from MIFAC

    Time frame: Day 20 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  8. Fractional iron absorption from MIFAC

    Time frame: Day 30 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  9. Fractional iron absorption from MIFAC

    Time frame: Day 40 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  10. Fractional iron absorption from MIFAC

    Time frame: Day 160 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  11. Fractional iron absorption from Control Ferrous Sulfate

    Time frame: Day 10 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  12. Fractional iron absorption from Control Ferrous Sulfate

    Time frame: Day 20 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  13. Fractional iron absorption from Control Ferrous Sulfate

    Time frame: Day 30 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  14. Fractional iron absorption from Control Ferrous Sulfate

    Time frame: Day 40 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

  15. Fractional iron absorption from Control Ferrous Sulfate

    Time frame: Day 160 of the study

    The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.

Secondary outcomes

  1. Haemoglobin

    Time frame: Day 1 of the study

    Haemoglobin status of the participants will be measured to check for anaemia status

  2. Haemoglobin

    Time frame: Day 10 of the study

    Haemoglobin status of the participants will be measured to check for anaemia status

  3. Haemoglobin

    Time frame: Day 20 of the study

    Haemoglobin status of the participants will be measured to check for anaemia status

  4. Haemoglobin

    Time frame: Day 30 of the study

    Haemoglobin status of the participants will be measured to check for anaemia status

  5. Haemoglobin

    Time frame: Day 40 of the study

    Haemoglobin status of the participants will be measured to check for anaemia status

  6. Haemoglobin

    Time frame: Day 160 of the study

    Haemoglobin status of the participants will be measured to check for anaemia status

  7. Ferritin

    Time frame: Day 1 of the study

    Ferritin levels will be measured to assess the iron stores in the participants.

  8. Ferritin

    Time frame: Day 10 of the study

    Ferritin levels will be measured to assess the iron stores in the participants.

  9. Ferritin

    Time frame: Day 20 of the study

    Ferritin levels will be measured to assess the iron stores in the participants.

  10. Ferritin

    Time frame: Day 30 of the study

    Ferritin levels will be measured to assess the iron stores in the participants.

  11. Ferritin

    Time frame: Day 40 of the study

    Ferritin levels will be measured to assess the iron stores in the participants.

  12. C-reactive Protein

    Time frame: Day 1 of the study

    Inflammation status of the participants will be measured since it has an effect on iron absorption

  13. C-reactive Protein

    Time frame: Day 10 of the study

    Inflammation status of the participants will be measured since it has an effect on iron absorption

  14. C-reactive Protein

    Time frame: Day 20 of the study

    Inflammation status of the participants will be measured since it has an effect on iron absorption

  15. C-reactive Protein

    Time frame: Day 30 of the study

    Inflammation status of the participants will be measured since it has an effect on iron absorption

  16. C-reactive Protein

    Time frame: Day 40 of the study

    Inflammation status of the participants will be measured since it has an effect on iron absorption

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Mibelle AG

Registry information

Official study title

An Iron Isotope Study in Humans to Evaluate the Iron Bioavailability of a Novel Iron Compound - Iron Fatty Acid Complex

Acronym: IFAC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2019
Registry last updated
Aug 28, 2019

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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