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CompletedNCT00525317Updated Dec 17, 2013

Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

A Phase 4 interventional study of "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) in Cramps, sponsored by Oslo University Hospital. Completed. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2013-12-17.

Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cramps

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Keywords

  • Pregnancy
  • Magnesium
  • Leg Pain
03

In context

Muscle Cramp

95 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 85 interventional studies indexed under Muscle Cramp.

Browse Muscle Cramp studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Twin pregnancy.
  • Oedema.
  • Pre-eclampsia.
  • Magnesium supplementation beyond the trial treatment.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (actual)

Study arms

  • 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)

  • Placebo comparator
    Placebo tablet suplementation (2)

    Placebo (3 times daily for 2 weeks)

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

Interventions

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

    120 mg x 3 or placebo

    Also known as: Nycoplus Magnesium tablets(R), Placebo tablets

06

What researchers measure

Primary outcomes

  1. Pain intensity and frequency

    Time frame: end of study

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00525317
Lead sponsor
Oslo University Hospital
Collaborators
Takeda Nycomed, Sykehuset Asker og Baerum
Responsible party
Sponsor
First posted
Sep 5, 2007
Start date
Jan 2002
Primary completion
Sep 2004
Completion
Sep 2004
Last update
Dec 17, 2013

Study contacts

Thomas Bohmer, MD
principal investigator · Aker Universituy Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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