Iron Status and Human Metabolism

July 15, 2022 updated by: University of Oxford

Effects of Endogenous Iron Status and Intravenous Iron on Human Skeletal Muscle Metabolism at Rest and During Exercise

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • University of Oxford OCMR & CCRF, John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Iron-deficient, given placebo
Iron-deficient participants given an infusion of sodium chloride at conclusion of baseline experimental visit
Drug: Sodium chloride (placebo)
Infusion of 250 mL 0.9% sodium chloride
Other Names:
  • Normal saline
Active Comparator: Iron-deficient, given iron
Iron-deficient participants given an infusion of ferric carboxymaltose at conclusion of baseline experimental visit
Drug: Ferric carboxymaltose
Infusion of 15 mg/kg (up to maximum 1000 mg) ferric carboxymaltose in 250 mL 0.9% sodium chloride
Other Names:
  • Ferinject
Placebo Comparator: Iron-replete, given placebo
Iron-replete participants given an infusion of sodium chloride at conclusion of baseline experimental visit
Drug: Sodium chloride (placebo)
Infusion of 250 mL 0.9% sodium chloride
Other Names:
  • Normal saline
Active Comparator: Iron-replete, given iron
Iron-deficient participants given an infusion of ferric carboxymaltose at conclusion of baseline experimental visit
Drug: Ferric carboxymaltose
Infusion of 15 mg/kg (up to maximum 1000 mg) ferric carboxymaltose in 250 mL 0.9% sodium chloride
Other Names:
  • Ferinject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phosphocreatine depletion during small muscle mass exercise
Time Frame: 36 minute long graded exercise test; performed at baseline and follow-up visits (approximately a week apart)
Degree of phosphocreatine depletion during graded exercise of calf muscle assessed using magnetic resonance spectroscopy
36 minute long graded exercise test; performed at baseline and follow-up visits (approximately a week apart)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary exercise test performance
Time Frame: Hour long graded exercise test; performed at baseline and follow-up visits (approximately a week apart)
Blood lactate and cardiorespiratory parameters during moderate large skeletal muscle mass exercise, assessed with cardiopulmonary exercise testing
Hour long graded exercise test; performed at baseline and follow-up visits (approximately a week apart)
Muscle biopsy findings
Time Frame: Immediately before and immediately after hour long cardiopulmonary exercise test, performed at baseline and follow-up visits (approximately a week apart)
Skeletal muscle characteristics, assessed by minimally-invasive muscle biopsy (not a compulsory part of the protocol)
Immediately before and immediately after hour long cardiopulmonary exercise test, performed at baseline and follow-up visits (approximately a week apart)
Participant reported symptoms
Time Frame: At study screening visit compared to four weeks following infusion of iron or placebo
Measures of fatigue, restless-legs syndrome and well-being assessed by self-reported questionnaires
At study screening visit compared to four weeks following infusion of iron or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

British Heart Foundation
National Institute for Health Research, United Kingdom

Investigators

  • Study Director: Peter A Robbins, DPhil, University of Oxford
  • Principal Investigator: Matthew C Frise, MRCP, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/SC/0439

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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