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Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

Primary Purpose

Iron-deficiency, Iron Deficiency Anemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Reference
Ascorbic acid (AA) 500 mg
Ascorbic acid (AA) 80 mg
Coffee
Breakfast
Afternoon
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron-deficiency focused on measuring iron supplementation, women of reproductive age, iron absorption enhancers, iron absorption inhibitors, ferrous fumarate, iron deficiency

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female, 18 to 45 years old,
  • SF levels <30 μg/L,
  • Body weight < 70 kg
  • Normal Body Mass Index (18.5-25 kg/m2),
  • Signed informed consent.

Exclusion Criteria:

  • Anemia (Hb < 12 g/dL)
  • Elevated CRP > 5 mg/L,
  • Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism,
  • Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism,
  • Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection,
  • Difficulties with blood sampling,
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
  • Known hypersensitivity or allergy to iron capsules in the given amount (ferrous fumarate, brilliant blue FCF (E133), titandioxide (E171) and sodium lauryl sulfate)
  • Pregnancy, breastfeeding
  • Women who intend to become pregnant during the course of the study,
  • Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse,
  • Smokers (> 1 cigarette per week),
  • Participant is likely to be absent on one the study appointments,
  • Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.

Sites / Locations

  • ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Reference

Ascorbic acid (AA) 500 mg

Ascorbic acid (AA) 80 mg

Coffee

Breakfast

Afternoon

Arm Description

Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe).

Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 500 mg AA.

Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) and 80 mg AA.

Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe) and 150 mL coffee.

Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 1 bread roll (~100 g) with butter and honey, 1 cup of plain yoghurt (180 mL), 1 cup of coffee (150 mL) and 1 glass of orange juice (250 mL).

Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) in the afternoon .

Outcomes

Primary Outcome Measures

Fractional iron absorption [percent]
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Fractional iron absorption [percent]
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Total iron absorption [mg]
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Total iron absorption [mg]
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

Secondary Outcome Measures

Hemoglobin (Hb)
Iron status marker
Serum ferritin (SF)
Iron status marker
Serum transferrin receptor (sTfR)
Iron status marker
Serum iron (SFe)
Iron status marker
Total iron binding capacity (TIBC)
Iron status marker
Hepcidin
Iron regulatory protein
C-reactive protein (CRP)
Inflammation marker
Alpha-1-acid-glycoprotein (AGP)
Inflammation marker

Full Information

First Posted
May 13, 2022
Last Updated
June 9, 2022
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05414474
Brief Title
Effects of Enhancers and Inhibitors on Absorption From Iron Supplements
Official Title
Effects of Nutritional Iron Absorption Enhancers and Inhibitors and Daytime on Absorption From Oral Iron Supplements
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

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
Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are recommended to be taken on an empty stomach in the morning and without a meal to avoid any interaction with phytic acid, another iron absorption inhibitor present in many foods. However, the effects of these iron absorption enhancers and inhibitors have only been shown on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin increase on absorption from an iron supplement given in the afternoon without a preceding morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon decreases iron bioavailability from a supplemental dose is uncertain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia
Keywords
iron supplementation, women of reproductive age, iron absorption enhancers, iron absorption inhibitors, ferrous fumarate, iron deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reference
Arm Type
Active Comparator
Arm Description
Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe).
Arm Title
Ascorbic acid (AA) 500 mg
Arm Type
Experimental
Arm Description
Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 500 mg AA.
Arm Title
Ascorbic acid (AA) 80 mg
Arm Type
Experimental
Arm Description
Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) and 80 mg AA.
Arm Title
Coffee
Arm Type
Experimental
Arm Description
Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 54Fe) and 150 mL coffee.
Arm Title
Breakfast
Arm Type
Experimental
Arm Description
Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 57Fe) and 1 bread roll (~100 g) with butter and honey, 1 cup of plain yoghurt (180 mL), 1 cup of coffee (150 mL) and 1 glass of orange juice (250 mL).
Arm Title
Afternoon
Arm Type
Experimental
Arm Description
Ferrum Hausmann 100 mg is consumed with 200 mL nanopure water with labelled ferrous fumarate (3 mg 58Fe) in the afternoon .
Intervention Type
Other
Intervention Name(s)
Reference
Intervention Description
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes
Intervention Type
Other
Intervention Name(s)
Ascorbic acid (AA) 500 mg
Intervention Description
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 500 mg AA
Intervention Type
Other
Intervention Name(s)
Ascorbic acid (AA) 80 mg
Intervention Description
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe + 80 mg AA
Intervention Type
Other
Intervention Name(s)
Coffee
Intervention Description
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes + 150 mL coffee
Intervention Type
Other
Intervention Name(s)
Breakfast
Intervention Description
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 1 bread roll (~100 g) with butter and honey + 1 cup of plain yoghurt (180 mL) + 1 cup of coffee (150 mL) + 1 glass of orange juice (250 mL)
Intervention Type
Other
Intervention Name(s)
Afternoon
Intervention Description
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe isotopes administered in the afternoon
Primary Outcome Measure Information:
Title
Fractional iron absorption [percent]
Description
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Time Frame
Day 22
Title
Fractional iron absorption [percent]
Description
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Time Frame
Day 43
Title
Total iron absorption [mg]
Description
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Time Frame
Day 22
Title
Total iron absorption [mg]
Description
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Hemoglobin (Hb)
Description
Iron status marker
Time Frame
Day 1, 22, 26 and 43
Title
Serum ferritin (SF)
Description
Iron status marker
Time Frame
Day 1, 22, 26 and 43
Title
Serum transferrin receptor (sTfR)
Description
Iron status marker
Time Frame
Day 1, 22, 26 and 43
Title
Serum iron (SFe)
Description
Iron status marker
Time Frame
Day 1, 22, 26 and 43
Title
Total iron binding capacity (TIBC)
Description
Iron status marker
Time Frame
Day 1, 22, 26 and 43
Title
Hepcidin
Description
Iron regulatory protein
Time Frame
Day 1, 22 and 26
Title
C-reactive protein (CRP)
Description
Inflammation marker
Time Frame
Day 1, 22, 26 and 43
Title
Alpha-1-acid-glycoprotein (AGP)
Description
Inflammation marker
Time Frame
Day 1, 22, 26 and 43

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female, 18 to 45 years old, SF levels <30 μg/L, Body weight < 70 kg Normal Body Mass Index (18.5-25 kg/m2), Signed informed consent. Exclusion Criteria: Anemia (Hb < 12 g/dL) Elevated CRP > 5 mg/L, Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism, Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism, Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection, Difficulties with blood sampling, Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months, Known hypersensitivity or allergy to iron capsules in the given amount (ferrous fumarate, brilliant blue FCF (E133), titandioxide (E171) and sodium lauryl sulfate) Pregnancy, breastfeeding Women who intend to become pregnant during the course of the study, Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse, Smokers (> 1 cigarette per week), Participant is likely to be absent on one the study appointments, Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna von Siebenthal, MSc
Phone
+41 44 632 53 73
Email
hanna.vonsiebenthal@hest.ethz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Stoffel, Dr.
Phone
+41 44 632 83 93
Email
nicole.stoffel@hest.ethz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Stoffel, Dr.
Organizational Affiliation
Human Nutrition Laboratory, ETH Zuerich
Official's Role
Principal Investigator
Facility Information:
Facility Name
ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health
City
Zürich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

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Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

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