Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

Cramps Clinical Trial

Official title:

Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525317
• Other study ID #: Oral magnesium in pregnance
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2007
• Last updated: December 16, 2013
• Start date: January 2002
• Est. completion date: September 2004

Study information

• Verified date: December 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cramps

Intervention

Drug:
• "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
120 mg x 3 or placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Sykehuset Asker og Baerum, Takeda Nycomed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity and frequency		end of study