Hosseini 2018.
Study characteristics | ||
Methods | Randomised clinical trial with parallel‐group design (2 groups) | |
Participants |
Country: Iran Number of participants randomised: 82 women, aged 18 to 50 years, mean age 34 years Inclusion criteria: BMI between 25 and 40 kg/m2 with NAFLD confirmed by single ultrasonographist, vitamin D insufficiency (serum 25‐hydroxyvitamin D < 30 ng/mL), not taking dietary supplements including calcium and vitamin D over the last 6 months Exclusion criteria: renal, hepatic, other endocrine disorders, malignancies, pregnancy and lactation, alcohol consumption, menopause condition, receiving medications influencing vitamin D metabolism or insulin |
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Interventions |
Intervention: vitamin D3 (cholecalciferol) 600,000 IU single intramuscular injection (n = 41) Control: no intervention (n = 41) All participants received pearl of vitamin E 400 IU/day for 1 month. Participants were followed up for 1 month. |
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Outcomes |
Primary outcomes: changes in serum 25‐hydroxyvitamin D, serum adiponectin, HOMA‐IR, liver enzymes, and change in grade of NAFLD Secondary outcomes: change in anthropometric variables |
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Stated aim of study | To examine the effect of single intramuscular injection of 600,000 IU of cholecalciferol on serum levels of vitamin D, adiponectin, insulin resistance, and liver function status of women with NAFLD | |
Notes | Study authors did not report any deaths. No information provided about adverse events. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patients were randomly assigned in the random blocks of four subjects using a computer Random Allocation Software, version 1, with stratification by age." |
Allocation concealment (selection bias) | Unclear risk | Method used to conceal the allocation not described, so intervention allocations may have been foreseen before, or during, enrolment. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data unlikely to make treatment effects depart from plausible values. |
Selective reporting (reporting bias) | Low risk | The trial was registered in the Iranian Registry of Clinical Trials with code number of IRCT201503163320N10. |
Other bias | Low risk | Trial appeared to be free of other factors that could put it at risk of bias. |