Khoranrodi 2011.
Study characteristics | ||
Methods | 2‐arm randomised controlled trial. | |
Participants | Setting: health centre ‐ Ali Ebn Abi Taleb Inciusion criteria: third trimester of pregnancy, single pregnancy, no consumption of any drug excepts for iron and multivitamins Exclusion criteria: irregular use of medication, PLP, unwilling to complete forms |
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Interventions | Intervention group: 500 mg calcium, daily for 4 weeks Control group: 1 placebo capsule (lactose Merk) daily for 4 weeks |
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Outcomes | Frequency and severity of leg cramp | |
Notes | Clinical Trials.gov ID IRCT201009274824N1 Dates of study: 2011‐02‐05 Funding sources: Research Managment Affairs, Bushehr University Of Medical Sciences Declarations of interest: there are no conflicts of interest. |
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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) | Unclear risk | Not specifically described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both healthcare providers and women were masked to treatment assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Women self‐reported outcomes. The treatment assignment was not revealed until data collection was completed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 women were excluded. Reasons are given |
Selective reporting (reporting bias) | Low risk | Assessed from study protocol and published report, all prespecified outcomes reported. |
Other bias | Unclear risk | Insufficient information available to assess whether another important risk of bias exists. |