Roth 2010.
Methods | Randomised placebo‐controlled trial (AViDD‐2 trial) | |
Participants | 160 pregnant women aged 18 < 35 years old, attending to the International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh (latitude: 23.7000° N, 90.3750° E, north of the Tropic of Cancer). Inclusion criteria: women with residence in Dhaka, with plans to have the delivery performed at the Shimantik maternity centre, and to stay in Dhaka throughout the pregnancy and 1 month past the delivery, with gestational age of 26th to 29th (inclusive), estimated based on the first day of the last menstrual period. Exclusion criteria: use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin D within the month prior to enrolment, or refusal to stop taking supplemental vitamin D at any dose after enrolment, current use of anti‐convulsant or anti‐mycobacterial (tuberculosis) medications, severe anaemia (haemoglobin concentration < 70 g/L), complicated medical or obstetric history: cardiovascular disease, uterine haemorrhage, placenta praevia, threatened abortion, hypertension, pre‐eclampsia, preterm labour, or multiple gestation), prior history of delivery of an infant with a major congenital anomaly, birth asphyxia, or perinatal death (stillbirth or death within first week of life). | |
Interventions | Participants were randomly assigned to 1 of 2 groups: group 1 (n = 80): women received vitamin D (cholecalciferol‐D3) 35,000 IU per week, started at 26 to 29 weeks' gestation, until delivery; group 2 (n = 80): women received placebo control administered weekly from 26 to 29 weeks' gestation until delivery. Health worker cadre: supplement doses were measured in disposable plastic syringes and orally administered by study personnel. |
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Outcomes | Maternal: serum 25‐hydroxyvitamin D concentration, serum calcium concentration, urine Ca:Cr ratio. Infant: immune function, infant growth, postnatal vitamin D status, serum calcium. Laboratory method used for assessment of vitamin D concentrations: Serum 25‐hydroxyvitamin D was quantified by high‐performance liquid chromatography tandem mass spectroscopy (LCMS/MS) in the Department of Pathology and Laboratory Medicine at the Hospital for Sick Children. |
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Notes |
Source of funding: this study was funded by a Non‐governmental organization (NGO). The Thrasher Research Fund, Salt Lake City, USA. Dates of the study and location: August 2010 to January 2011, Dhaka, Bangladesh. Declarations of interest among primary researchers (or state where this information is not reported by the trial authors): the authors declare that they have no competing interests. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Trial reported computer‐generated randomisation list for the randomisation procedures. |
Allocation concealment (selection bias) | Low risk | The allocation sequence was prepared by International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh personnel not otherwise involved in the study, and was concealed from investigators. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Trial reported that participants were blinded to allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Trial reported that research staff (including lab personnel) were blinded to allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Of the 160 participants recruited and randomly assigned to intervention or placebo, 13 were lost to follow‐up prior to delivery (6 in the placebo group and 7 in the vitamin D group), all because of having left the Dhaka area. |
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. |