Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

This study has been completed.
Sponsor:
Collaborators:
Takeda Nycomed
Sykehuset Asker og Baerum
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00525317
First received: September 4, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Cramps
Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
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:


Further study details as provided by Oslo University Hospital:

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

Enrollment: 45
Study Start Date: January 2002
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnesium tablet suplementation (1)
Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
120 mg x 3 or placebo
Other Names:
  • Nycoplus Magnesium tablets(R)
  • Placebo tablets
Placebo Comparator: Placebo tablet suplementation (2)
Placebo (3 times daily for 2 weeks)
Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
120 mg x 3 or placebo
Other Names:
  • Nycoplus Magnesium tablets(R)
  • Placebo tablets

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.

  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
Oslo University Hospital
Takeda Nycomed
Sykehuset Asker og Baerum
Investigators
Principal Investigator: Thomas Bohmer, MD Aker Universituy Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00525317     History of Changes
Other Study ID Numbers: Oral magnesium in pregnance
Study First Received: September 4, 2007
Last Updated: December 16, 2013
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Oslo University Hospital:
Pregnancy
Magnesium
Leg Pain

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 April 17, 2014