Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

NCT ID: NCT05414474

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2022-12-09

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.

Conditions

Iron-deficiency; Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference

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

Group Type: ACTIVE_COMPARATOR

Reference

Intervention Type: OTHER

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes

Ascorbic acid (AA) 500 mg

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

Group Type: EXPERIMENTAL

Ascorbic acid (AA) 500 mg

Intervention Type: OTHER

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 500 mg AA

Ascorbic acid (AA) 80 mg

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

Group Type: EXPERIMENTAL

Ascorbic acid (AA) 80 mg

Intervention Type: OTHER

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe + 80 mg AA

Coffee

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

Group Type: EXPERIMENTAL

Coffee

Intervention Type: OTHER

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes + 150 mL coffee

Breakfast

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).

Group Type: EXPERIMENTAL

Breakfast

Intervention Type: OTHER

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)

Afternoon

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

Group Type: EXPERIMENTAL

Afternoon

Intervention Type: OTHER

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe isotopes administered in the afternoon

Interventions

Reference

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes

Intervention Type: OTHER

Ascorbic acid (AA) 500 mg

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 500 mg AA

Intervention Type: OTHER

Ascorbic acid (AA) 80 mg

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe + 80 mg AA

Intervention Type: OTHER

Coffee

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes + 150 mL coffee

Intervention Type: OTHER

Breakfast

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

Afternoon

Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe isotopes administered in the afternoon

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Stoffel, Dr.

Role: PRINCIPAL_INVESTIGATOR

Human Nutrition Laboratory, ETH Zuerich

Locations

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

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

IDEA

Identifier Type: -

Identifier Source: org_study_id