Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome

NCT ID: NCT05467423

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2023-09-30

Brief Summary

Iron deficiency is a common problem that is often treated with the administration of oral iron.

Most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria.

This influence is usually undesirable and should be kept as small as possible. With lower iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the intestinal bacteria composition is to be expected.

Detailed Description

Iron deficiency affects about one in five premenopausal women. The first line treatment for patients with iron deficiency is an oral therapy with iron-supplements, another option is the intravenous iron supplementation.

The oral supplementation causes side-effects such as nausea, vomiting, abdominal pain and many more in a lot of patients. There is a positive correlation between the appearance of gastrointestinal side-effects and the applicated iron dose.

Only a low fraction of orally taken iron is actually absorbed, even in patients with iron-deficiency. Since only a fraction of the orally administered iron is actually absorbed, the toxicity of high concentrations of iron in the gastrointestinal tract and the altered selection advantages of the bacteria presumably leads to microbiome changes.

The unabsorbed iron is potentially changing the microbiome, which leads to undesirable side effects.

With low-dose iron-supplementation the amount of unabsorbed iron is smaller, therefore a dosage dependent microbiome change would be expected.

The aim of the study is to determine the magnitude of the microbiome response to daily iron substitution with 12mg and 100mg.

Conditions

Iron Deficiency (Without Anemia)

Keywords

Iron; Microbiome; Gut Bacteria

Study Design

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

Study Groups

Standard-dose

The standard-dose arm takes one 100mg of iron per day together with a meal, no matter breakfast, lunch or dinner - one tablet a day.

Group Type: ACTIVE_COMPARATOR

Iron

Intervention Type: DIETARY_SUPPLEMENT

4 weeks of daily oral iron therapy. The subjects administer the therapy themselves.

Low-dose

The low-dose arm 12mg of iron a day. The first 6mg tablet in the morning on an empty stomach and the second 6mg tablet in the evening either one hour before or after eating - two tablets a day.

Group Type: EXPERIMENTAL

Iron

Intervention Type: DIETARY_SUPPLEMENT

4 weeks of daily oral iron therapy. The subjects administer the therapy themselves.

Interventions

Iron

4 weeks of daily oral iron therapy. The subjects administer the therapy themselves.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Informed Consent as documented by signature
• Female gender
• Premenopausal
• Age > 18 years
• Regular menstrual cycle
• BMI in normal range (18-25kg/m2)
• Serum-ferritin ≤30ng/ml
• No anemia (hemoglobin ≥117g/l)
• No intake of dietary supplements for at least 4 weeks

Exclusion Criteria

• Pregnancy
• Hypermenorrhea (more than 5 unties/tampons per day)
• Chronic inflammatory disease, psychiatric disorders
• Hypersensitivity to iron supplements
• chronic kidney disease (creatinine >80 µmol/l)
• Liver disease (ALT >35 U/l)
• Hypo- or Hyperthyroidism (TSH not between 0.16-4.25 mU/l)
• Intake of medicines that interact with oral iron supplementation (e.g. PPI)*

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Pierre-Alexandre Krayenbuehl

Professor Pierre-Alexandra Krayenbuehl

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitätsspital Zürich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

IronGutMicrobiome

Identifier Type: -

Identifier Source: org_study_id