Iron Status and Human Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse outcome. This human physiology study will examine the extent to which human skeletal muscle metabolism and exercise physiology are impaired by iron deficiency.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Abdominal Adiposity and Muscle Mitochondrial Functions

NCT00446745

Mitochondrial Respiratory Chain Deficiencies

COMPLETED

Study of Muscle Repair Following Exercise in Young and Elderly People

NCT02174692

Healthy

COMPLETED NA

Study of the Effects of Temperature on Metabolism in Human Muscle

NCT00001753

Healthy

COMPLETED PHASE1

Trial of the Effects of Remote Preconditioning on the Tissue Metabolism During Exercise and Ischemia

NCT00791206

Ischemia

UNKNOWN PHASE2

Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue

NCT00004914

Anemia Fatigue Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective double-blind randomised controlled study of the effect of endogenous iron status on skeletal muscle metabolism and exercise physiology. 32 healthy volunteers will take part, half of whom will be iron-deficient. The study involves a screening visit and two half-day visits during which assessments are performed. 50% of each group will be randomised to receive iron-repletion with ferric carboxymaltose at the end of the first experimental visit before returning to repeat identical assessments around one week later. This approach will make it possible to explore whether baseline differences in skeletal muscle metabolism are explained by differences in iron status per se, whilst controlling for any learning effect during participation in the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iron-deficient, given placebo

Iron-deficient participants given an infusion of sodium chloride at conclusion of baseline experimental visit

Group Type PLACEBO_COMPARATOR

Sodium chloride (placebo)

Intervention Type DRUG

Infusion of 250 mL 0.9% sodium chloride

Iron-deficient, given iron

Iron-deficient participants given an infusion of ferric carboxymaltose at conclusion of baseline experimental visit

Group Type ACTIVE_COMPARATOR

Ferric carboxymaltose

Intervention Type DRUG

Infusion of 15 mg/kg (up to maximum 1000 mg) ferric carboxymaltose in 250 mL 0.9% sodium chloride

Iron-replete, given placebo

Iron-replete participants given an infusion of sodium chloride at conclusion of baseline experimental visit

Group Type PLACEBO_COMPARATOR

Sodium chloride (placebo)

Intervention Type DRUG

Infusion of 250 mL 0.9% sodium chloride

Iron-replete, given iron

Iron-deficient participants given an infusion of ferric carboxymaltose at conclusion of baseline experimental visit

Group Type ACTIVE_COMPARATOR

Ferric carboxymaltose

Intervention Type DRUG

Infusion of 15 mg/kg (up to maximum 1000 mg) ferric carboxymaltose in 250 mL 0.9% sodium chloride

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ferric carboxymaltose

Infusion of 15 mg/kg (up to maximum 1000 mg) ferric carboxymaltose in 250 mL 0.9% sodium chloride

Intervention Type DRUG

Sodium chloride (placebo)

Infusion of 250 mL 0.9% sodium chloride

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ferinject Normal saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to give informed consent for participation in the study
* Men and women aged 18 years or older and generally in good health
* For iron-deficient volunteers: ferritin ≤ 15 microg/L and transferrin saturation \< 16%
* For iron-replete volunteers: ferritin ≥ 20 microg/L and transferrin saturation ≥ 20%

Exclusion Criteria

* Haemoglobin \< 8.0 g/dL
* Haemoglobinopathy
* Iron overload, defined as ferritin \> 300 microg/L
* Hypoxaemia (SpO2 \< 94%) or significant co-morbidity that may affect haematinics, metabolic or ventilatory responses
* Iron supplementation or blood transfusion within the previous 6 weeks
* Pregnancy or breast feeding
* Inability to exercise isolated calf muscle using a pedal or on a bicycle ergometer
* Contraindication to magnetic resonance spectroscopy exposure such as metallic implant
* Contraindication to receiving intravenous ferric carboxymaltose

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes