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

NCT05467423 | Completed

• 1 other identifier: IronGutMicrobiome
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency (Without Anemia)

Keywords

Iron; Microbiome; Gut Bacteria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Side-effects of treatment

  4 weeks

Study Arms (2)

Standard-dose

ACTIVE COMPARATOR

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.

Dietary Supplement: Iron

Low-dose

EXPERIMENTAL

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.

Dietary Supplement: Iron

Interventions

Iron DIETARY_SUPPLEMENT

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

Low-dose; Standard-dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)\*

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Iron

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pierre-Alexandra Krayenbuehl

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 20, 2022
• Study Start: January 4, 2023
• Primary Completion: April 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)