NCT03014921

Brief Summary

This trial study and compare in blood and urinary matrices the impact of an iron injection on proteins involved in iron metabolism during a blood donation. The goal is to study the impact of an iron injection on detection markers of a blood donation in the anti-doping field

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
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
unknown

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

Study Start

First participant enrolled

December 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

December 23, 2016

Last Update Submit

January 6, 2017

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

  • Serum ferritin level variations due to iron injection or blood donation

    measurements will be done in ug/l

    8 weeks

Secondary Outcomes (2)

  • Hemoglobin level variations due to iron injection or blood donation

    8 weeks

  • Reticulocyte% variations due to iron injection or blood donation

    8 weeks

Study Arms (2)

placebo injection group

PLACEBO COMPARATOR

saline solution injection as placebo

Other: saline solution injection

iron injection group

ACTIVE COMPARATOR

iron injection

Other: iron injection

Interventions

iron injectionOTHER

Injection of a 250mL saline solution added with 500mg of iron (Ferinject)

iron injection group
saline solution injectionOTHER

Injection of a 250mL saline solution

placebo injection group

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male between 20 and 35 yo
  • BMI between 18 and 30
  • Ferritin \< 50ug/l
  • Transferrin saturation \< 20 if ferritin between 20 and 50ug/l

You may not qualify if:

  • high level athlete
  • blood donation within 6 months before the study
  • liver disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Iron Deficiencies

Interventions

IronSaline Solution

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 9, 2017

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

January 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share