Hammar 1987.
Study characteristics | ||
Methods | 2‐arm randomised controlled trial, with 13 additional controls without leg cramps (not included in analysis). | |
Participants | Setting: Sweden.
Inclusion criteria: pregnant women who had experienced leg cramps for more than 2 weeks. Exclusion criteria: not described |
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Interventions | Experimental intervention: oral calcium preparation containing calcium gluconate, calcium lactate and calcium carbonate corresponding to a calcium dose of 1 g twice daily for 3 weeks (30 women). Comparison intervention: vitamin C 1 g twice daily for 3 weeks (30 women). |
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Outcomes | Frequency of cramps, serum calcium, magnesium and albumin concentrations. | |
Notes | Dates of study: this information is not reported by the trial authors Funding sources: ACO Research Fund Declarations of interest: this information is not reported by the trial authors |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study states that it was “randomised”, but there is no description of the method. |
Allocation concealment (selection bias) | Low risk | Not specifically described, but the code was not broken until all women had completed the investigation, which suggests that allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The study was double‐blinded, and the code was not broken until all women had completed the investigation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The code was not broken until all women had completed the investigation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women appear to be accounted for in the analysis. |
Selective reporting (reporting bias) | Unclear risk | Assessed from published report, without protocol. Focus is on biochemical outcomes, but all prespecified outcomes appear to be reported. |
Other bias | Unclear risk | Insufficient information to assess whether another important risk of bias exists. |