Iron Isotope Study of an Iron Fatty Acid Complex

NCT03895424 | Completed DMC

• 1 other identifier: IFAC
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron-deficiency

Keywords

Iron; Isotope study; Fatty Acid

Outcome Measures

Primary Outcomes (15)

• Fractional iron absorption from IFAC

  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.

  Day 10 of the study

• Fractional iron absorption from IFAC

  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.

  Day 20 of the study

• Fractional iron absorption from IFAC

  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.

  Day 30 of the study

• Fractional iron absorption from IFAC

  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.

  Day 40 of the study

• Fractional iron absorption from IFAC

  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.

  Day 160 of the study

• Fractional iron absorption from MIFAC

  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.

  Day 10 of the study

• Fractional iron absorption from MIFAC

  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.

  Day 20 of the study

• Fractional iron absorption from MIFAC

  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.

  Day 30 of the study

• Fractional iron absorption from MIFAC

  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.

  Day 40 of the study

• Fractional iron absorption from MIFAC

  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.

  Day 160 of the study

• Fractional iron absorption from Control Ferrous Sulfate

  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.

  Day 10 of the study

• Fractional iron absorption from Control Ferrous Sulfate

  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.

  Day 20 of the study

• Fractional iron absorption from Control Ferrous Sulfate

  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.

  Day 30 of the study

• Fractional iron absorption from Control Ferrous Sulfate

  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.

  Day 40 of the study

• Fractional iron absorption from Control Ferrous Sulfate

  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.

  Day 160 of the study

Secondary Outcomes (16)

• Haemoglobin

  Day 1 of the study

• Haemoglobin

  Day 10 of the study

• Haemoglobin

  Day 20 of the study

• Haemoglobin

  Day 30 of the study

• Haemoglobin

  Day 40 of the study

Study Arms (3)

Iron Fatty Acid Complex (IFAC)

EXPERIMENTAL

The iron fatty acid complex encapsulated and administered to the participants

Dietary Supplement: IFAC

Micellarized iron fatty acid complex (MIFAC)

EXPERIMENTAL

Micellarized form of the iron fatty acid complex which is enscapsulated and administered to the participants

Dietary Supplement: MIFAC

Control Ferrous Sulfate

ACTIVE COMPARATOR

Ferrous sulfate that is provided in the form of a solution along with a capsule that contains the same amount of fat that is present in the other two arms.

Dietary Supplement: Control Ferrous Sulfate

Interventions

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

Iron Fatty Acid Complex (IFAC)

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

Micellarized iron fatty acid complex (MIFAC)

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

Control Ferrous Sulfate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only females are allowed to participate in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Mibelle AG: collaborator

Study Sites (1)

Lab of Human Nutrition, ETH Zurich

Zurich, Canton of Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Zimmermann, PhD

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 29, 2019
• Study Start: January 7, 2019
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CH (1)