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Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00525317
Collaborator
Takeda Nycomed (Other), Sykehuset Asker og Baerum (Other)
45
Enrollment
2
Arms
32
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
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 :
Jan 1, 2002
Actual Primary Completion Date :
Sep 1, 2004
Actual Study Completion Date :
Sep 1, 2004

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain intensity and frequency [end of study]

    Eligibility Criteria

    Criteria

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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Oslo University Hospital
    • Takeda Nycomed
    • Sykehuset Asker og Baerum

    Investigators

    • Principal Investigator: Thomas Bohmer, MD, Aker Universituy Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT00525317
    Other Study ID Numbers:
    • Oral magnesium in pregnance
    First Posted:
    Sep 5, 2007
    Last Update Posted:
    Dec 17, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Oslo University Hospital
    Pregnancy
    Magnesium
    Leg Pain
    Additional relevant MeSH terms:
    Muscle Cramp

    Study Results

    No Results Posted as of Dec 17, 2013