Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ? - Full Text View

Sponsors and Collaborators:	University Hospital, Aker Nycomed,Hospital Asker and Bærum HF
Information provided by:	University Hospital, Aker
ClinicalTrials.gov Identifier:	NCT00525317

Purpose

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

Condition	Intervention	Phase
Leg Cramps	Drug: Nycoplus Magnesium	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?

Resource links provided by NLM:

MedlinePlus related topics: Muscle Cramps

Drug Information available for: Magnesium

U.S. FDA Resources

Further study details as provided by University Hospital, Aker:

Primary Outcome Measures:

Pain intensity and frequency [ Time Frame: end of study ]

Enrollment:	45
Study Start Date:	January 2002
Study Completion Date:	September 2004

Arms	Assigned Interventions
1: Active Comparator Nycoplus Magnesium(R)	Drug: Nycoplus Magnesium 120 mg x 3 or placebo
2: Placebo Comparator Placebo	Drug: Nycoplus Magnesium 120 mg x 3 or placebo

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.Frequency and intensity of leg cramps were recorded both for night and day.45 women were enrolled in the study and 38 completed the study protocol.

Registration of pain frequency and intensity during the two study demonstrated no significant difference between the groups. There was a statistical significant increase in magnesium excreation in the mangesium treatment group(p=0.0065). The laboratory tests demonstrated no significant differences between the groups when comparing serum values of magnesium and calcium at inclusion time and at the end of the treatment.

Eligibility

Ages Eligible for Study:	18 Years to 38 Years
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525317

Sponsors and Collaborators

University Hospital, Aker

Nycomed,Hospital Asker and Bærum HF

Investigators

Principal Investigator:

Thomas Bohmer, MD

Aker Universituy Hospital

More Information

No publications provided

Study ID Numbers:	Leg cramps in pregnancy, -
Study First Received:	September 4, 2007
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00525317 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital, Aker:

Pregnancy
Magnesium
Leg cramps

Study placed in the following topic categories:

Muscle Cramp

ClinicalTrials.gov processed this record on September 11, 2009