Assessing the Immediate Increase in Serum Ferritin After... | NCT06657677

Studies
Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses

NCT06657677

Sponsor

Jessica Rigutto

Status

Completed

Last Update Posted

Feb 27, 2025Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Iron Deficiency (Without Anemia)

Interventions

40mg oral iron dosing
100mg oral iron dosing
180mg oral iron dosing

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

Status Module

Record Verification Date

Oct 2024

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

Oct 25, 2024Actual

Primary Completion Date

Dec 16, 2024Actual

Completion Date

Dec 16, 2024Actual

First Submitted Date

Oct 23, 2024

First Submission Date that Met QC Criteria

Oct 23, 2024

First Posted Date

Oct 24, 2024Actual

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

Feb 24, 2025

Last Update Posted Date

Feb 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin, as well as its protein characteristics, following the administration of a single iron dose

Detailed Description

Not provided

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
40 mg	Experimental	single dose of 40 mg oral iron	Dietary Supplement: 40mg oral iron dosing
100 mg	Experimental	single dose of 100 mg oral iron	Dietary Supplement: 100mg oral iron dosing
180 mg	Experimental	single dose of 180 mg oral iron	Dietary Supplement: 180mg oral iron dosing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
40mg oral iron dosing	Dietary Supplement	Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate	40 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum ferritin	Serum ferritin concentration	study day 1
Serum ferritin	Serum ferritin concentration	study day 7

Secondary Outcomes

Measure	Description	Time Frame
C-reactive protein	C-reactive protein concentration in serum	study day 0
Serum ferritin	Serum ferritin concentration	study day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low iron stores (SF levels < 30 µg/L),
no anemia (Hb > 120 g/L)
no inflammation (CRP < 5 mg/L)
18 to 45 years old.
Body weight <70 kg
Normal body Mass Index (18.5-26.5 kg/m2)

Exclusion Criteria:

Any chronic or acute disease
Consumption of mineral and vitamin supplements since screening and over the study period
Blood transfusion, blood donation or significant blood loss over the past 6 months,
Pregnant or breastfeeding,
Continuous/long-term use of medication during the whole studies (except for contraceptives)
Therapeutic iron infusion over the past 6 months,
Known hypersensitivity or allergy to iron supplements,
Intention to become pregnant over the course of the study

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicole Stoffel, PhD	ETH Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ETH Zurich		Zurich	Canton of Zurich	8092	Switzerland
Laboratory of Nutrition and Metabolic Epigenetics

IPD Sharing Statement Module

Plan to Share IPD

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

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Browse Branches

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