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Completed

NCT Number: NCT05467423

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsspital Zürich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)*

Treatment and study plan

Iron

Dietary Supplement

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

Primary outcomes

  1. Microbiome diversity and oral iron therapy

    Time frame: 4 weeks

    The microbiome is analyzed using stool samples. A stool sample is taken before and after the 4 weeks period. The low-dose arm is expected to have a smaller decrease compared to the standard-dose arm. The microbiome composition is measured using 16S rDNA gene amplicon sequencing. The results are analysed using the Shannon-Index to include diversity as well as abundance.

Secondary outcomes

  1. Side-effects of treatment

    Time frame: 4 weeks

    Adverse events will be assessed on a report form after 4 weeks

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Single Center Clinical Trial to Evaluate the Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome in Non-anemic Iron-deficient Females

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2022
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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