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Effects of Iron Supplementation on Skeletal Muscle Properties in Females With Suboptimal Iron Storage

NCT07084298 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-06

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether oral iron supplementation will increase skeletal muscle iron storage and its effects on exercise capacity in females with suboptimal iron status. The study will include healthy females, ages 18-40, who either have suboptimal or optimal iron stores.

The main questions it aims to answer are:

* Does iron supplementation increase skeletal muscle iron storage and alter the expression of iron-related and mitochondrial proteins?
* Does iron supplementation improve single-leg exercise performance?
* Is serum ferritin correlated with the abundance of iron-related proteins in skeletal muscle?

Researchers will compare outcomes from females with suboptimal iron status who receive oral iron supplementation to those who receive a placebo to see if supplementation improves muscle iron storage, protein expression, and exercise performance. Additionally, a non-intervention control group with optimal iron status will be included to assess baseline differences.

Participants will:

\- Be randomly assigned to receive 150 mg elemental iron or placebo (maltodextrin) every other day for 12 weeks

Complete pre- and post-supplementation testing, including:

* Blood draws to assess iron status
* Skeletal muscle biopsies to analyze protein content
* Whole-body and single-leg exercise tests to assess performance
* Controls will undergo baseline-only testing to compare physiological and biochemical markers

Conditions

Interventions

DIETARY_SUPPLEMENT

Oral iron supplement

Encapsulated ferrous sulphate (150mg elemental iron)

OTHER

Placebo

Encapsulated polysaccharide (maltodextrin)

Sponsors & Collaborators

  • Natural Sciences and Engineering Research Council, Canada

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Martin J MacInnis · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084298 on ClinicalTrials.gov