Sasan 2017.
Methods | Randomised controlled clinical trial. | |
Participants | 142 women who were referred to the obstetrical clinic in Besat Hospital of Sanandaj City, Kurdistan Province, Iran, who were receiving prenatal care and had a history of pre‐eclampsia in previous pregnancies. | |
Interventions | The participants were randomly placed into 2 groups: Group 1 (n = 70) received 50,000 IU pearl vitamin D3 once every 2 weeks; and Group 2 (n = 72) received placebo. Vitamin D or placebo was given until the 36th week of pregnancy. Health worker cadre: not specified. |
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Outcomes | Maternal: level of vitamin D, pre‐eclampsia. Laboratory method used for assessment of vitamin D concentrations: level of vitamin D was determined through Liebermann–Burchard method. |
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Notes |
Source of funding: unknown/unreported. Dates of the study: not reported dates, Iran. Declarations of interest among primary researchers (or state where this information is not reported by the trial authors): the authors announce that there are no conflicts of interest between different individuals and organisations involved in the study. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 140 pockets of drug and placebo were randomly (by using table of random numbers). |
Allocation concealment (selection bias) | Unclear risk | 140 pockets of drug and placebo were randomly offered and both study staff and participants did not know about administration of the treatments. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both study staff and participants did not know about administration of the treatments. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both study staff and participants did not know about administration of the treatments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data reported for all participants. |
Selective reporting (reporting bias) | Unclear risk | Although participant's level of 25‐hydroxy vitamin D was used to determine study eligibility, serum levels of vitamin D were not reported. |
Other bias | Low risk | The study appears to be free of other sources of bias. |