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Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

NCT ID: NCT00525317

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cramps

Keywords

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Pregnancy Magnesium Leg Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Magnesium tablet suplementation (1)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

120 mg x 3 or placebo

Placebo tablet suplementation (2)

Placebo (3 times daily for 2 weeks)

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

120 mg x 3 or placebo

Interventions

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

120 mg x 3 or placebo

Intervention Type DRUG

Other Intervention Names

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Nycoplus Magnesium tablets(R) Placebo tablets

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Takeda Nycomed

UNKNOWN

Sponsor Role collaborator

Sykehuset Asker og Baerum

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Bohmer, MD

Role: PRINCIPAL_INVESTIGATOR

Aker Universituy Hospital

Other Identifiers

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Oral magnesium in pregnance

Identifier Type: -

Identifier Source: org_study_id