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Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

This study has been completed.
Sponsor:
Collaborator:
Nycomed,Hospital Asker and Bærum HF
Information provided by:
University Hospital, Aker
ClinicalTrials.gov Identifier:
NCT00525317
First received: September 4, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

This is a trial of treament with tablets containing magnesium for leg cramps in pregnancy.


Condition Intervention Phase
Leg Cramps
 Drug: Nycoplus Magnesium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?

Resource links provided by NLM:

MedlinePlus related topics: Muscle Cramps
Drug Information available for: Magnesium
U.S. FDA Resources

Further study details as provided by University Hospital, Aker:

Primary Outcome Measures:
  • Pain intensity and frequency [ Time Frame: end of study ]

Enrollment: 45
Study Start Date: January 2002
Study Completion Date: September 2004
Arms Assigned Interventions
Active Comparator: 1
Nycoplus Magnesium(R)
 Drug: Nycoplus Magnesium
120 mg x 3 or placebo
Placebo Comparator: 2
Placebo
 Drug: Nycoplus Magnesium
120 mg x 3 or placebo

Detailed Description:

Healthy pregnant women between 18 and 36 weeks of pregnancy suffering from leg cramps at least twice a week were treated with magnesium tablets or placebo for two weeks, 120 mg x 3 daily.Frequency and intensity of leg cramps were recorded both for night and day.45 women were enrolled in the study and 38 completed the study protocol. Registration of pain frequency and intensity during the two study demonstrated no significant difference between the groups. There was a statistical significant increase in magnesium excreation in the mangesium treatment group(p=0.0065). The laboratory tests demonstrated no significant differences between the groups when comparing serum values of magnesium and calcium at inclusion time and at the end of the treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with recurrent leg cramps (at least twice a week).
  • No disease according to helath certificate. Written participation consent must be signed.
  • Linguistic ability demanded: Norwegian as the first language. Gestation length more than 17 weeks, less than 36 weeks.

Exclusion Criteria:

  • Twin pregnancy.
  • Oedema.
  • Pre-eclampsia.
  • Magnesium supplementation beyond the trial treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525317

Sponsors and Collaborators
University Hospital, Aker
Nycomed,Hospital Asker and Bærum HF
Investigators
Principal Investigator: Thomas Bohmer, MD Aker Universituy Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00525317     History of Changes
Other Study ID Numbers: Leg cramps in pregnancy
Study First Received: September 4, 2007
Last Updated: September 4, 2007
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital, Aker:
Pregnancy
Magnesium
Leg cramps

Additional relevant MeSH terms:
Muscle Cramp
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013