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Completed

NCT Number: NCT02308449

Iron Status and Human Metabolism

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oxford OCMR & CCRF, John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferric carboxymaltose

Drug

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

Other names: Ferinject

Sodium chloride (placebo)

Drug

Infusion of 250 mL 0.9% sodium chloride

Other names: Normal saline

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • British Heart Foundation
  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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