Shakiba 2013.
Methods | Randomised clinical trial | |
Participants | Healthy, pregnant women from the beginning of their second trimester of pregnancy. Exclusion criteria were not explicitly stated. |
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Interventions | Group A (n = 17): 50,000 IU/month. Group B (n = 17): 100,000 IU/month (50,000 IU every 2 weeks). Group C (n = 17): vitamin D deficient women (25(OH)D levels < 20 ng/mL) were treated with a total of 200,000 IU (50,000 IU/week for 4 weeks), followed by supplementation with 50,000 IU/month. Health worker cadre: the women were randomly recruited from 2 primary care clinics, a locality known to have a high prevalence of vitamin D deficiency, in Yazd (31°53’50”N/54°22’04”E), Iran (north of tropics), where > 90% of the days are sunny. Obstetricians and midwives conducted monthly visits to ensure that the participants adhered to the recommended dosage of vitamin D3. A paediatrician examined the neonate for possible anomalies and recorded the anthropometric measurements at the time of delivery. Other health workers not mentioned. |
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Outcomes |
Maternal Secondary
Infant Primary
Secondary (infant)
Laboratory method used for assessment of vitamin D concentrations: Chemiluminescence immunoassays (DiaSorin, spA, Via Crescentino, Vercelli, Italy) |
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Notes | • Start of supplementation: second trimester • Pre‐gestational BMI (kg/m2): unknown/mixed; • Supplementation scheme/regimen: weekly/monthly • Skin pigmentation based on Fitzpatrick skin tone chart (Fitzpatrick 1988): not available • Latitude: north of Tropics • Season at the start of pregnancy: autumn and winter of 2009 Source of funding: not reported. Dates of the study: not described. Declarations of interest among primary researchers: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation. Of the 51 participants, 34 were randomly classified into 2 groups (Groups A and B) and the remaining 17 women, were allocated to Group C based on their serum 25(OH)D levels |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to allow judgement. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding was not reported in the study. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding was not reported in the study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all mentioned outcomes (methods), including those that were pre‐specified. |
Other bias | Unclear risk | Insufficient information to allow judgement. |