NCT06264687

Brief Summary

The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 9, 2024

Last Update Submit

February 18, 2024

Conditions

Iron Deficiency (Without Anemia)

Outcome Measures

Primary Outcomes (1)

  • Serum Hepcidin Change

    The change of serum hepcidin levels over time (days 0, 2, 7) after intravenous iron administration.

    1 week

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

iron deficient non-anemic women

You may qualify if:

  • informed consent as documented by signature
  • iron-deficiency (serum ferritin \<30ng/ml)
  • female gender
  • premenopausal
  • age \>18 years
  • body mass index (BMI) in normal range (18-25 kg/m²)
  • the participant is linguistically and cognitively able to understand the study procedure

You may not qualify if:

  • anaemia (hemoglobin \<117g/l)
  • allergy or contraindications for iron infusions
  • anamnestic current pregnancy
  • breastfeeding
  • chronic inflammatory diseases (e.g. colitis)
  • liver disease (alanine transaminase (ALT) \>35 U/l)
  • increased C-reactive protein (CRP) (\>5mg/l)
  • intake of dietary supplements containing iron (last 7 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 20, 2024

Study Start

March 1, 2024

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02