Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

December 16, 2013 updated by: Oslo University Hospital

Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

45

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • Placebo tablets
  • Nycoplus Magnesium tablets(R)
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:
  • Placebo tablets
  • Nycoplus Magnesium tablets(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity and frequency
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Takeda Nycomed
Sykehuset Asker og Baerum

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (Estimate)

September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral magnesium in pregnance

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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