NCT06338787

Brief Summary

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 17, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

March 24, 2024

Last Update Submit

May 26, 2025

Conditions

Iron Deficiencies

Keywords

ironmicrobiotaexercise

Outcome Measures

Primary Outcomes (3)

  • Iron Status

    Ferritin

    Baseline, 4 weeks, 8 weeks

  • Hemoglobin

    Hemoglobin concentration

    Baseline, 4 weeks, 8 weeks

  • Lower Gut microbiome

    Fecal sample

    Baseline, 4 weeks, 8 weeks

Secondary Outcomes (1)

  • Exercise Capacity

    Baseline, 4 weeks, 8 weeks

Other Outcomes (4)

  • Gastrointestinal Symptoms 1

    Weekly for 8 weeks

  • Gastrointestinal Symptoms 2

    Weekly for 8 weeks

  • Sleepiness

    Weekly for 8 weeks

  • +1 more other outcomes

Study Arms (1)

Iron/yeast complex (FeSC)

EXPERIMENTAL

Iron Supplement

Other: FeSC

Interventions

FeSCOTHER

Iron/yeast complex

Iron/yeast complex (FeSC)

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • cis-gendered female 14-18 years old
  • sub-optimal iron status (ferritin ≤45mcg/ L)
  • At least 1 year past the age of menarche
  • Engage in moderate to vigorous endurance activity for at least 3 hours a week

You may not qualify if:

  • Supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months
  • antibiotic use in last 3 months
  • \- Energy availability \>30 kcal/kg lean body mass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2n4N1, Canada

Location

MeSH Terms

Conditions

Iron DeficienciesMotor Activity

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Jane Shearer, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 1, 2024

Study Start

June 17, 2024

Primary Completion

March 12, 2025

Study Completion

December 1, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)