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Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

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ClinicalTrials.gov Identifier: NCT00525317
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : December 17, 2013
Sponsor:
Collaborators:
Takeda Nycomed
Sykehuset Asker og Baerum
Information provided by (Responsible Party):
Oslo University Hospital

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

Condition or disease Intervention/treatment Phase
Cramps Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?
Study Start Date : January 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525317


Sponsors and Collaborators
Oslo University Hospital
Takeda Nycomed
Sykehuset Asker og Baerum
Investigators
Principal Investigator: Thomas Bohmer, MD Aker Universituy Hospital

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00525317     History of Changes
Other Study ID Numbers: Oral magnesium in pregnance
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

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