Li 2000a.
Methods | Clinical controlled trial with 3 arms. | |
Participants | 88 pregnant women with a predisposition to pregnancy‐induced hypertension, at 20 to 24 weeks' gestation, a BMI index of lower than 24, and an arterial pressure of < 11.3 kPa attending an outpatient clinic and labour ward of the First Afilliated Hospital of Xi’an Medical University, Xi’an, China. | |
Interventions | Participants were divided into 3 groups: group 1 (n = 29) received a daily dose of a tablet containing 600 mg of calcium and 200 IU of vitamin D (Caltrate‐D) daily from 20 to 24 weeks until deliver; group 2 (n = 29) received 1200 mg of calcium and 400 IU vitamin D (Caltrate‐D) daily from 20 to 24 weeks until deliver; group 3 (n = 30) received no intervention from 20 to 24 weeks until delivery. Health worker cadre: not specified. |
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Outcomes | Maternal: blood pressure, ionised calcium and platelet intracellular calcium, incidence rates of pregnancy‐induced hypertension. Laboratory method used for assessment of vitamin D concentrations: not applicable. |
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Notes |
Source of funding: unknown/unreported. Dates of the study and location: August 1996 to December 1998, China. Declarations of interest among primary researchers (or state where this information is not reported by the trial authors): none declared. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | The trial did not report if participants were randomly allocated to the treatment groups. It is unclear if it was random or not. |
Allocation concealment (selection bias) | Unclear risk | The trial did not report the method of concealment. It is assumed that it was not conceal as one of the groups did not receive any supplementation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial did not report if it was blinded. It is assumed that it was not blinded to participants as one of the groups did not receive any supplementation. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The trial did not mention if the study was single or double blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up not reported. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to make a judgement. |
Other bias | High risk | The report is very short, with most details of the methods not available. |