Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Deficiency Anemia; Iron-deficiency

Treatments: Other: Ascorbic acid (AA) 80 mg; Other: Breakfast; Other: Reference; Other: Afternoon; Other: Coffee; Other: Ascorbic acid (AA) 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05414474

IDEA

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

35 participants in 6 patient groups

Reference

Active Comparator group

Description:

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

Treatment:

Other: Reference

Ascorbic acid (AA) 500 mg

Experimental group

Description:

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

Treatment:

Other: Ascorbic acid (AA) 500 mg

Ascorbic acid (AA) 80 mg

Experimental group

Description:

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

Treatment:

Other: Ascorbic acid (AA) 80 mg

Coffee

Experimental group

Description:

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

Treatment:

Other: Coffee

Breakfast

Experimental group

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).

Treatment:

Other: Breakfast

Afternoon

Experimental group

Description:

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

Treatment:

Other: Afternoon