Asemi 2016.
Methods | Double‐blind parallel‐arm RCT, individual randomisation, placebo controlled | |
Participants | Setting: clinics in Kashan, Iran. Dates of recruitment: March‐September 2012. Inclusion criteria: 46 women, 18‐40 with singleton pregnancy. Exclusion criteria: women with pre‐eclampsia, placental abruption and GDM (it appeared that women were excluded after randomisation). |
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Interventions | Experimental intervention: calcium‐vitamin D for 9 weeks from 25 weeks (500 mg calcium, 200 IU vitamin D per day). Total number randomised: n = 23. Control/comparison intervention: placebo pills of similar appearance. Total number randomised: n = 23. Women in both groups took iron and folic acid supplements. |
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Outcomes | Fasting plasma glucose, insulin metabolism, biomarkers of oxidative stress, vitamin D levels, BP, birth size, gestational age, mode of birth. | |
Notes | Author contacted re information about women excluded after randomisation. Funding: reported to be funded by a grant from the vice‐chancellor for research, Kashan university of medical sciences. Reported that supplements and placebo were provided by Shahre Daru Co, Tehran. CoI: reported no conflict of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | It was reported that randomisation was by random numbers “taken from a computer”. |
Allocation concealment (selection bias) | Unclear risk | Placebo controlled but method at point of randomisation not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not clear if staff blind. Placebo controlled but it was not clear if staff were aware. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not clear if outcome assessors blind, some outcomes may not be affected by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 4 women were excluded post‐randomisation for reasons that may have related to the intervention (participants that developed complications during the trial were excluded – we have added these back in and collected these data for our analysis). |
Selective reporting (reporting bias) | Unclear risk | We had no protocol. Women were excluded post‐randomisation and no ITT. |
Other bias | Unclear risk | Author contacted re post‐randomisation exclusions. |