CrampsPhase 4NCT00525317
Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?
A Phase 4 study testing "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) in people with Cramps, run by Oslo University Hospital.
Trial summary
This is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Cramps
- What is being tested?
- "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Sep 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Twin pregnancy.
- Oedema.
- Pre-eclampsia.
- Magnesium supplementation beyond the trial treatment.
About this study
Official title: Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?
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.
- Conditions
- Cramps
- Being tested
- "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)
- Keywords
- Pregnancy, Magnesium, Leg Pain
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)Drug
Also called Nycoplus Magnesium tablets(R), Placebo tablets
120 mg x 3 or placebo
| Study group | Role | What they receive |
|---|---|---|
| Magnesium tablet suplementation (1) | Active comparator | Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) Receives: Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) |
| Placebo tablet suplementation (2) | Placebo comparator | Placebo (3 times daily for 2 weeks) Receives: Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity and frequency
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJan 2002
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CrampsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Nycomed, Sykehuset Asker og Baerum
- Responsible party
- Sponsor
- Investigators
- Thomas Bohmer, MD, Principal investigator, Aker Universituy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525317
- Sponsor's protocol ID
- Oral magnesium in pregnance
- Status last verified
- Dec 2013
- First submitted
- 4 Sep 2007
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?
- ClinicalTrials.gov ID
- NCT00525317
- Acronym / sponsor ID
- Oral magnesium in pregnance
- Conditions
- Cramps
- Keywords
- Pregnancy, Magnesium, Leg Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Takeda Nycomed, Sykehuset Asker og Baerum
- Study start
- Jan 2002
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium tablet suplementation (1) | Active comparator | Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) |
| Placebo tablet suplementation (2) | Placebo comparator | Drug: "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)Placebo (3 times daily for 2 weeks) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Twin pregnancy.
- Oedema.
- Pre-eclampsia.
- Magnesium supplementation beyond the trial treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks)Also: Nycoplus Magnesium tablets(R), Placebo tablets120 mg x 3 or placebo | Drug | Magnesium tablet suplementation (1), Placebo tablet suplementation (2) |
Primary outcome
Pain intensity and frequency
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bohmer, MD principal investigator
Aker Universituy Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "Nycoplus Magnesium" (120 mg x 3 daily for 2 weeks) in people with Cramps, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity and frequency (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.