Marya 1987.
Methods | Randomised controlled trial; 2‐arm design with randomisation at individual level. | |
Participants | 400 pregnant women 20 to 35 years of age, attending the antenatal clinic of Medical College Hospital in Rohtak, India (latitude: 76° 34' 0' north of Tropic of Cancer). Pre‐gestational BMI and skin pigmentation not reported. | |
Interventions | Participants were allocated to 1 of 2 groups: group 1 (n = 200) received a daily supplement containing 1200 IU vitamin D and 375 mg calcium (estimated total dose from week 20 to 24 of gestation to term:134,400‐168,000 IU); group 2 (n = 200) received no supplement from 20 to 24 weeks of pregnancy until delivery and served as controls. Length of the intervention/follow‐up: 20 to 24 weeks from start of supplementation to term. Health worker cadre: not specified. |
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Outcomes | Maternal: pre‐eclampsia (defined as blood pressure of 140 mmHg or higher systolic and/or 90 mmHg diastolic along with proteinuria higher than 300 mg/24 hours); systolic and diastolic blood pressure at 24, 28, 32 and 36 weeks of gestation. Serum calcium and creatinine. Laboratory method used for assessment of vitamin D concentrations: not applicable. |
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Notes | Biochemical analyses were made for those who developed pre‐eclampsia (n = 12) and also in a group of women with no pre‐eclampsia (n = 25) and a control group of non pregnant women. The results of the stratified analysis are not reported in this review.
Source of funding: unknown/unreported. Dates of the study and location: not reported dates, India. 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) | Unclear risk | The trial reported that participants were randomly allocated to the intervention groups but they did not report the method of sequence generation. |
Allocation concealment (selection bias) | Unclear risk | The trial did not report the method of concealment. It is assumed that they did not conceal the allocation 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 the study 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 report if the research staff was blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only data on biochemical were reported for those who developed pre‐eclampsia and some of those with no pre‐eclampsia and a group of non pregnant controls. |
Selective reporting (reporting bias) | High risk | Outcomes reported for some subgroups only. |
Other bias | Low risk | The study appears to be free of other sources of bias. |