Low-dose Iron Supplementation in Non-anaemic Iron-deficie... | NCT05869422

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

NCT05869422

Sponsor

Dr. Krayenbühl GmbH

Status

Completed

Last Update Posted

Jun 11, 2025Actual

Enrollment

59Actual

Phase

Not Applicable

Conditions

Iron Deficiency (Without Anemia)

Interventions

Iron
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SNCTP000005680	Registry Identifier	Swiss National Clinical Trial Portal (SNCTP)

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 6, 2024Actual

Primary Completion Date

Dec 21, 2024Actual

Completion Date

Dec 21, 2024Actual

First Submitted Date

May 11, 2023

First Submission Date that Met QC Criteria

May 11, 2023

First Posted Date

May 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2025

Last Update Posted Date

Jun 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	placebo tablet containing no iron	Other: Placebo
Low Dose Iron	Experimental	low-dose tablet containing 6mg of iron	Dietary Supplement: Iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron	Dietary Supplement	60 ± 5 days of daily oral iron supplementation.	Low Dose Iron

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Zurich		Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000090463	Iron Deficiencies

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007501	Iron

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements

Browse Leaves

Not provided

Browse Branches

Not provided