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

Iron Deficiency (Without Anemia) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467423
• Other study ID #: IronGutMicrobiome
• Status: Completed
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)*

Related Conditions & MeSH terms

• Iron Deficiency (Without Anemia)

Intervention

Dietary Supplement:
• Iron
4 weeks of daily oral iron therapy. The subjects administer the therapy themselves.

Locations

Country	Name	City	State
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome diversity and oral iron therapy	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.	4 weeks
Secondary	Side-effects of treatment	Adverse events will be assessed on a report form after 4 weeks	4 weeks