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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014