Mirghafourvand 2013.
Methods | Triple‐blind randomised controlled clinical trial. | |
Participants | 126 pregnant women, aged 18 to 39 years with gestational age of 25 to 30 weeks referring to Tabriz health centres, Iran in 2013 to 2014. | |
Interventions | Participants were allocated to 3 groups using a randomised block design with block sizes of 3 and 6 with the allocation ratio 1:1:1: group 1 (n = 40) Calcium‐vitamin D group (300 mg carbonate calcium plus 1000 units of vitamin D supplements; group 2 (n = 42) vitamin D group (1000 units of vitamin D supplements; and group 3 (n = 42) received placebo. To hide the allocation, each participant received 2 small envelopes, each with enough medicine for 3 weeks, inside a large matte‐coloured envelope of the same shape that were serially numbered. Each participant received 1 pill every day for 42 days. All pills were of the same shape, size, and weight. Health worker cadre: not specified. |
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Outcomes | Maternal: gestational age, mode of delivery based on gestational age. food consumption, in terms of calcium and vitamin D content, pre‐pregnancy BMI, BMI during pregnancy Infant: weight, height, and head circumference, birthweight, height, head circumference. Laboratory method used for assessment of vitamin D concentrations: not specified. |
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Notes |
Source of funding: this study was funded by a research grant of Tabriz University of Medical Sciences (Project number: 388). Dates of the study and location: July 2013 to April 2014, Iran. Declarations of interest among primary researchers (or state where this information is not reported by the trial authors): no conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were allocated to 3 groups using a randomised block design with block sizes of 3 and 6 with the allocation ratio 1:1:1. |
Allocation concealment (selection bias) | Unclear risk | To hide the allocation, each participant received 2 small envelopes, each with enough medicine for 3 weeks, inside a large matte‐coloured envelope of the same shape that were serially numbered. Each participant received 1 pill every day for 42 days. Pills were of the same shape, size, and weight. However, authors did not mention how this was concealed from study staff. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded to the study treatments. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The trial reported that it was double‐blinded but they did not specify if those performing the assessments were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up were documented. No missing data and no participant was eliminated from the analysis. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Low risk | The study appears to be free of other sources of bias. |