Asemi 2013a.
Methods | Randomised, double‐blind, placebo‐controlled clinical trial with 2 arms: vitamin D and placebo, during March 2012 to September 2012. | |
Participants | 48 healthy pregnant women, primigravida, aged 18–40 years old at 25 weeks of gestation and a singleton pregnancy attending maternity clinics affiliated with Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran. Women with pre‐eclampsia, hypertension, GDM, IUFD, or those with a history of rheumatoid arthritis, hepatic or renal failure, metabolic bone disease and malabsorption, or thyroid, parathyroid, or adrenal diseases were excluded from the analysis. Also, smokers and those taking medications including nonsteroidal antiinflammatory drugs and aspirin were excluded. | |
Interventions | Participants were randomly assigned to receive 1 of 2 groups: group 1 (n = 24) received 400 IU vitamin D (cholecalciferol‐D3) supplements daily; and group 2 (n = 24) received placebo for 9 weeks. Additionally, all participants also consumed 400 mcg (0.4 mg) folic acid daily from the beginning of pregnancy and 60 mg elemental iron (as ferrous sulphate) daily from the second trimester. Health worker cadre: the trial was carried out in maternity clinics affiliated to Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran and the investigators provided the supplements to the participants. A trained midwife at the maternity clinic performed anthropometric measurements at study baseline and at 6 weeks after the intervention. |
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Outcomes | Maternal: weight, height, BMI, systolic blood pressure and diastolic blood pressure, serum calcium concentrations, serum 25‐hydroxyvitamin D [25(OH)D], serum hs‐C‐reactive protein, fasting plasma glucose, serum cholesterol, LDL‐cholesterol, HDL‐cholesterol concentrations, serum insulin, quantitative Insulin sensitivity check index (QUICKI) score, plasma total antioxidant capacity, plasma total glutathione, GDM, preterm delivery, IUFD, placental abruption, severe pre‐eclampsia. Laboratory method used for assessment of vitamin D concentrations: serum 25‐hydroxyvitamin D concentrations were measured using a commercial ELISA kit (Immuno Diagnostic Systems). |
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Notes |
Source of funding: study was funded by research grant from the Vice‐chancellor for Research, Kashan University of Medical Sciences, Kashan, Iran. Dates of the study and location: March 2012 to September 2012, Kashan, 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 | Random assignment was performed by the use of computer‐generated random numbers. |
Allocation concealment (selection bias) | Low risk | A trained midwife at the maternity clinic performed the randomised allocation sequence and assigned participants to the groups. Placebo pills contained microcrystalline cellulose and were packed in identical tablets and coded by the producer to guarantee blinding. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and investigators were blind to the interventions. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Measurements of laboratory were performed in a blinded fashion, in duplicate, in pairs (before/after intervention) at the same time, in the same analytical run, and in random order to reduce systematic error and inter assay variability. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 in each group were lost to follow‐up. |
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. |