Sabet 2012.
Methods | Randomised, double‐blind trial | |
Participants | 50 pregnant women, in their third trimester, who were scheduled to deliver at Mahdieh Hospital in Tehran. | |
Interventions | Participants were randomly allocated to 1 of 2 groups: Group 1 (n = 25) received oral vitamin D3 100,000 IU monthly, 3 times; Group 2 (n = 25) control (placebo); until term. Health worker cadre: not specified. |
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Outcomes | Maternal: the final maternal 25(OH) serum concentrations at delivery, cord 25(OH) vitamin D concentration serum 25(OH), maternal serum iPTH and cord blood iPTH concentration mean PTH concentration Infant: serum vitamin D lower than30 ng/mL in newborn infants Laboratory method used for assessment of vitamin D concentrations: Serum 25 (OH) D concentrations were measured by EIA using the 25(OH) Vit D kit (Immune diagnostic system Ltd, Bolden, UK). |
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Notes |
Source of funding: this study was funded by a research grant from the Research Institute of Endocrine Sciences, Shahid Beheshti University of Medical Sciences. Dates of the study and location: 2009 to 2010, Tehran, Iran. Declarations of interest among primary researchers (or state where this information is not reported by the trial authors): no conflict of interest declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly allocated to the treatment or placebo but methods describing this process were not reported. |
Allocation concealment (selection bias) | Unclear risk | The trial reported that it was double‐blinded, but no methods of describing the process were reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The trial reported that it was double‐blinded, but no methods of describing the process were reported. |
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 | Data reported for all 50 participants. |
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. |