NCT00525317

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

2.7 years

First QC Date

September 4, 2007

Last Update Submit

December 16, 2013

Conditions

Cramps

Keywords

PregnancyMagnesiumLeg Pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity and frequency

    end of study

Study Arms (2)

Magnesium tablet suplementation (1)

ACTIVE COMPARATOR

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

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

Placebo tablet suplementation (2)

PLACEBO COMPARATOR

Placebo (3 times daily for 2 weeks)

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

Interventions

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

120 mg x 3 or placebo

Also known as: Nycoplus Magnesium tablets(R), Placebo tablets
Magnesium tablet suplementation (1)Placebo tablet suplementation (2)

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Twin pregnancy.
  • Oedema.
  • Pre-eclampsia.
  • Magnesium supplementation beyond the trial treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscle Cramp

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Bohmer, MD

    Aker Universituy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

January 1, 2002

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

December 17, 2013

Record last verified: 2013-12