Skip to main content
. 2020 Sep 21;2020(9):CD009402. doi: 10.1002/14651858.CD009402.pub3

Nygaard 2008.

Study characteristics
Methods Double‐blind, parallel‐group RCT
Participants 45 pregnant women with rest cramps and no previous cramp treatment. Recruitment by pamphlets provided to pregnant Norwegian women undergoing 18‐week ultrasound
Interventions Either a chewable tablet containing 122 mg elemental magnesium ("primarily as Mg lactate and Mg citrate") (n = 23), or a matched placebo tablet (n = 22), taken once each morning and twice each evening for 2 weeks
Outcomes Number of days or nights in which cramps occurred over 2 weeks
Degree of cramp pain on a 5‐point ordinal scale
Side effects
Serum magnesium and calcium and 24‐hour urinary magnesium on days 1 and 15
Conflicts of interest 1 author contributed in developing the magnesium tablet in 1985, and he received a compensation from Nycomed for this effort. The rest of the authors have no conflict of interest.
Funding Source of funding not provided
Notes Published. Conducted from August 2000 to January 2003
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “The randomization program was provided by Medstat Research AS.”
Comment: probably adequate; however, the frequency of cramping at baseline was not assessed, making it impossible to tell if the group was imbalanced in this important baseline characteristic
Allocation concealment (selection bias) Unclear risk No description of any method of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: “Both groups received a plastic container with the trial medication, 42 chewable tablets...”, containing either magnesium or placebo, both provided by the manufacturer
Comment: probably adequate
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcomes measured from forms completed by blinded participants
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 7/45 women (15.6%) dropped out (2 from the treatment arm and 5 from control). Reasons were given and most were unrelated to potential drug effects. None of the 7 dropouts were included in the analysis, because of a lack of data
Selective reporting (reporting bias) Low risk Primary outcome assumed to be the number of days and nights with cramping, but not explicitly stated. All outcomes reported
Cramp diary (recall bias) Low risk Diary used
Other bias Low risk No other obvious bias