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
2 other identifiers
interventional
59
1 country
1
Brief Summary
The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2024
CompletedJune 11, 2025
June 1, 2025
8 months
May 11, 2023
June 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum-ferritin change
significant change of serum-ferritin under supplementation
60 ± 5 days
Secondary Outcomes (3)
Blood Pressure
60 ± 5 days
Blood Sugar
60 ± 5 days
Lipid Status
60 ± 5 days
Other Outcomes (1)
Safety Endpoint
60 ± 5 days
Study Arms (2)
Placebo
PLACEBO COMPARATORplacebo tablet containing no iron
Low Dose Iron
EXPERIMENTALlow-dose tablet containing 6mg of iron
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Zurich
Zurich, Canton of Zurich, 8091, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- study employees
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med.
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 22, 2023
Study Start
May 6, 2024
Primary Completion
December 21, 2024
Study Completion
December 21, 2024
Last Updated
June 11, 2025
Record last verified: 2025-06