Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

NCT05414474 | Completed

• 1 other identifier: IDEA
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

iron supplementation; women of reproductive age; iron absorption enhancers; iron absorption inhibitors; ferrous fumarate; iron deficiency

Outcome Measures

Primary Outcomes (4)

• 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.

  Day 22

• 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.

  Day 43

• 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.

  Day 22

• 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.

  Day 43

Secondary Outcomes (8)

• Hemoglobin (Hb)

  Day 1, 22, 26 and 43

• Serum ferritin (SF)

  Day 1, 22, 26 and 43

• Serum transferrin receptor (sTfR)

  Day 1, 22, 26 and 43

• Serum iron (SFe)

  Day 1, 22, 26 and 43

• Total iron binding capacity (TIBC)

  Day 1, 22, 26 and 43

Study Arms (6)

Reference

ACTIVE COMPARATOR

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

Other: Reference

Ascorbic acid (AA) 500 mg

EXPERIMENTAL

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

Other: Ascorbic acid (AA) 500 mg

Ascorbic acid (AA) 80 mg

EXPERIMENTAL

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

Other: Ascorbic acid (AA) 80 mg

Coffee

EXPERIMENTAL

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

Other: Coffee

Breakfast

EXPERIMENTAL

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).

Other: Breakfast

Afternoon

EXPERIMENTAL

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

Other: Afternoon

Interventions

Reference OTHER

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

Reference

Ascorbic acid (AA) 500 mg OTHER

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

Ascorbic acid (AA) 500 mg

Ascorbic acid (AA) 80 mg OTHER

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

Ascorbic acid (AA) 80 mg

Coffee OTHER

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

Coffee

Breakfast 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)

Breakfast

Afternoon OTHER

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

Afternoon

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

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

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

Ascorbic Acid; Coffee; Breakfast

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Meals; Food

Study Officials

• Nicole Stoffel, Dr.

  Human Nutrition Laboratory, ETH Zuerich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 10, 2022
• Study Start: June 20, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CH (1)