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Completed

NCT Number: NCT00423540

Exploring the Role of Magnesium in Rest Cramps

This study sets out to show whether infusions of magnesium can lessen the frequency of rest cramps and to determine whether rest cramp sufferers have a deficiency in magnesium.

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Key information

Conditions

Rest Cramps Deficiency Diseases Magnesium Deficiency Malnutrition Mental Disorders Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Sleep-Wake Transition Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richmond Hospital

Richmond, British Columbia, V7C 4W7, Canada

About this study

Subjects will be randomized to receive 5 days of 4 hour IV infusions of D5W either with or without 20 mmol magnesium sulfate added. Twenty four hour urinary excretion of magnesium will be determined on the first day of infusions to assess whether magnesium deficiency is present. Ten normal controls will also undergo a single infusion and collection of urine to serve as a comparison group for the urinary excretion data.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≥2 leg or foot cramps per week in a 4 week run-in diary

Exclusion criteria

  • eGFR<50
  • Neurologic disease
  • Pregnancy
  • Heart block
  • Bradyarhythmia without pacemaker
  • Digoxin use
  • Liver disease
  • Addison's disease
  • History of MI
  • CHF
  • Absence of detectable reflexes

Treatment and study plan

Intravenous Infusion of Magnesium Sulfate

Drug

See Detailed Description.

Primary outcomes

  1. Change in the frequency of leg cramps per week (active versus placebo) over the first 30 days post infusions compared to the 30 days prior to randomization (as recorded in patient diaries).

    Time frame: See above

Secondary outcomes

  1. Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions.

  2. Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/"bothersome" over the 3 months. following infusions.

    Time frame: See above

  3. Overall quality of life changes as measured by an SF36 questionnaire.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Vancouver Coastal Health Research Institute

Registry information

Official study title

Magnesium Status & Effect of Magnesium Infusions on Rest Cramps

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 18, 2007
Registry last updated
Dec 10, 2008

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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