Mutlu 2014.
Methods | Randomised clinical trial | |
Participants | At least 16 years old and up to 42 years old (traditional dressing style), with a singleton pregnancy, having no previously known Cancer or untreated thyroidal disorders | |
Interventions | Women randomised to: ‐ Group 1: 1200 IU/d of vitamin D3; ‐ Group 2: 2000 IU/d form of vitamin D3 (50,000 units of cholecalciferol/15 mL). Health worker cadre: recruitment for the study was done by an obstetrician and paediatric endocrinologist in the Kocaeli Maternity and Children Hospital outpatient obstetric clinics (Turkey, north of tropics). It was not stated who administered the supplements nor who measured the outcomes. |
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Outcomes |
Maternal Primary
Infant Secondary
Laboratory method used for assessment of vitamin D concentrations: Enzyme immunoassay method (IDS ‐ Immunodiagnostic Systems) |
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Notes | • Start of supplementation:earliest at 13 weeks, latest at 32 • Pre‐gestational BMI (kg/m2): unknown/mixed; • Supplementation scheme/regimen: daily • Skin pigmentation based on Fitzpatrick skin tone chart (Fitzpatrick 1988): not available • Latitude: north of Tropics • Season at the start of pregnancy: spring Source of funding: not available Dates of the study: April 2011 – April 2012 Declarations of interest among primary researchers: this information is not reported by the trial authors |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Women were randomised using a simple randomisation method. Details on simple randomisation method used not provided. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | This was an unblinded study. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | This was an unblinded study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data seems to have been reported for all participants who completed the study. G1:n = 28 (7 lost to follow‐up, 3 withdrawals, 4 could not be contacted); G2:n = 31 (7 lost to follow‐up, 4 withdrawals, 3 could not be contacted); G3:n = 32 (9 lost to follow‐up, 7 withdrawals, 2 could not be contacted). |
Selective reporting (reporting bias) | Low risk | All intended outcomes (methods) were reported |
Other bias | Unclear risk | There is insufficient information to allow judgement. |