Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women (PCLDIT)

Randomised, Double-blind, Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

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

Study Overview

• Status: Completed
• Conditions: Iron Deficiency (Without Anemia)
• Intervention / Treatment: Other: Placebo; Dietary supplement: Iron

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo tablet containing no iron	Other: Placebo; 60 ± 5 days of daily oral placebo intake.
Experimental: Low Dose Iron; low-dose tablet containing 6mg of iron	Dietary supplement: Iron; 60 ± 5 days of daily oral iron supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum-ferritin change	significant change of serum-ferritin under supplementation	60 ± 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	change of blood pressure (systolic and diastolic blood pressure)	60 ± 5 days
Blood Sugar	change of blood sugar levels	60 ± 5 days
Lipid Status	change of lipid status (total cholesterol, HDL, LDL, triglycerides)	60 ± 5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Incidence of adverse events during 2 months under low dose iron supplementation and placebo treatment.	60 ± 5 days

Collaborators and Investigators

• Sponsor: Dr. Krayenbühl GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): December 21, 2024
• Study Completion (Actual): December 21, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: iron deficiency; iron therapy; low dose iron therapy
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Iron Deficiencies; Anemia, Iron-Deficiency
• Other Study ID Numbers: LowDoseIronVsPlacebo; SNCTP000005680 (Registry Identifier: Swiss National Clinical Trial Portal (SNCTP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No