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Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

Primary Purpose

Cramps

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
"Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cramps focused on measuring Pregnancy, Magnesium, Leg Pain

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Magnesium tablet suplementation (1)

    Placebo tablet suplementation (2)

    Arm Description

    Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)

    Placebo (3 times daily for 2 weeks)

    Outcomes

    Primary Outcome Measures

    Pain intensity and frequency

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2007
    Last Updated
    December 16, 2013
    Sponsor
    Oslo University Hospital
    Collaborators
    Takeda Nycomed, Sykehuset Asker og Baerum
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00525317
    Brief Title
    Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?
    Official Title
    Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    September 2004 (Actual)
    Study Completion Date
    September 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    Takeda Nycomed, Sykehuset Asker og Baerum

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cramps
    Keywords
    Pregnancy, Magnesium, Leg Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Magnesium tablet suplementation (1)
    Arm Type
    Active Comparator
    Arm Description
    Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
    Arm Title
    Placebo tablet suplementation (2)
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (3 times daily for 2 weeks)
    Intervention Type
    Drug
    Intervention Name(s)
    "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
    Other Intervention Name(s)
    Nycoplus Magnesium tablets(R), Placebo tablets
    Intervention Description
    120 mg x 3 or placebo
    Primary Outcome Measure Information:
    Title
    Pain intensity and frequency
    Time Frame
    end of study

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Bohmer, MD
    Organizational Affiliation
    Aker Universituy Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

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