Tehrani 2014.
Methods | Single‐arm study, not blinded. | |
Participants | 210 pregnant women referring to obstetric clinic of Shahid Beheshti and Alzahra hospital in Esfahan city in 2012. Inclusion criteria: patient satisfaction; normal BMI; gestational age below 16 weeks; no history of diabetes mellitus type 2 or GDM; no family history of diabetes mellitus type 1 in first degree relatives. Exclusion criteria: patient dissatisfaction; incorrect consumption of vitamin D supplementation; follow‐up discontinuation. | |
Interventions | Participants will be individually randomised to 1 of 2 groups: Group 1 (n = 70) received vitamin D supplementation with dose of 50,000 unit every 2 weeks for 10 weeks; Group 2 received a placebo. Pregnant women with levels of above 25 nmol/L were selected as the normal healthy control group and were the ones who received placebo. Health worker cadre: not specified. |
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Outcomes | Maternal: gestational blood sugar level, serum vitamin D level. 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 non‐governmental organization, Sponsor: Isfahan University of Medical Sciences. Dates of the study and location: January 2013 to January 2014, Iran. Declarations of interest among primary researchers (or state where this information is not reported by the trial authors): there are 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 randomised by table of random numbers. |
Allocation concealment (selection bias) | Low risk | Researcher, the distributors of the drug and the women, did not know which group was taken the vitamin D or placebo. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Researcher, the distributors of the drug and the women, did not know which group was taken the vitamin D or placebo. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Researcher, the distributors of the drug and the women, did not know which group was taken the vitamin D or placebo. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data reported. |
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 evident sources of bias. |