Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

NCT ID: NCT05869422

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2024-12-21

Brief Summary

The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.

Detailed Description

The established therapy for iron-deficiency today is oral iron supplementation. However, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. There are some studies that have compared the efficacy of low-dose iron with normal-dose iron. These showed that the side effects are dose-dependent. Furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. In a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. Therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. Additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 2 months (60 days), the other one will get two placebo tablet for 2 months, accordingly.

Conditions

Iron Deficiency (Without Anemia)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

placebo tablet containing no iron

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

60 ± 5 days of daily oral placebo intake.

Low Dose Iron

low-dose tablet containing 6mg of iron

Group Type: EXPERIMENTAL

Iron

Intervention Type: DIETARY_SUPPLEMENT

60 ± 5 days of daily oral iron supplementation.

Interventions

Iron

60 ± 5 days of daily oral iron supplementation.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

60 ± 5 days of daily oral placebo intake.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• informed consent as documented by signature
• female gender
• premenopausal
• age > 18 years
• regular menstrual cycle
• BMI in normal range (18-25 kg/m²)
• serum-ferritin ≤30µg/l
• no anaemia (Hemoglobin ≥117g/l)
• no intake of dietary supplements containing iron (last 4 weeks)
• the participant is linguistically and cognitively able to understand the study procedure

Exclusion Criteria

• Current pregnancy
• breastfeeding
• hypermenorrhea (more than 5 unties/tampons per day)
• chronic inflammatory diseases (e.g. colitis)
• psychiatric disorders
• chronic kidney disease (creatinine >80 µmol/l)
• liver disease (ALT >35 U/l)
• increased CRP (>5mg/l)
• hypersensitivity to iron-supplements
• 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: No

Sponsors

Dr. Krayenbühl GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Albina Nowak

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

SNCTP000005680

Identifier Type: REGISTRY

Identifier Source: secondary_id

LowDoseIronVsPlacebo

Identifier Type: -

Identifier Source: org_study_id