Ghaderi 2019.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Study grouping: Parallel group How were participants recruited: Study participants were approached at the psychiatry clinic Type of RCT: Randomized, double‐blind, placebo‐controlled trial |
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Participants |
Baseline characteristics Vitamin D + probiotic supplements
Placebo
Overall
Inclusion criteria: Any participant diagnosed with schizophrenia using DSM‐IV‐TR criteria with disease duration of at least two years, PANSS score of 55 or greater, treated with chlorpromazine (300 to 1000 mg/day, except clozapine) and agents anticholinergic (Trihexyphenidyl, 4 to 8 mg/day) during the last 6 months and aged 25 to 65 years old were included in the study. Exclusion criteria: Any participant with mental retardation (Intelligent Quotient of < 70), substance or alcohol addiction (except caffeine or nicotine) within the last 6 months of screening,a score of ≥14 on a 17‐item Hamilton Depression Rating Scale or a score of ≥ 4 on PANSS (depression item), anyone under treatment with lithium, carbamazepine, sodium valproic acid, with existing chronic and acute medical illness, with lactation or pregnancy, the use of antidepressants including MAO, TCA, SSRI in the last 6 months were excluded from this trials. Pretreatment: There was no significant difference between the two arms in terms of height, age, weight and BMI at baseline |
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Interventions |
Intervention characteristics Vitamin D + probiotic supplements
Placebo
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Outcomes |
Fasting plasma glucose
BMI
Cholesterol (Total cholesterol)
Drop‐outs
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Identification |
Sponsorship source: The research grant provided by Research Deputy of Kashan University ofMedical Sciences (KAUMS). Country: Iran Setting: Psychiatry clinic Comments: ‐ Authors name: Zatollah Asemi Institution: 8 Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences Email: asemi_r@yahoo.com Address: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R, Iran |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated random numbers were used by an instructed staff to randomize study participants at the psychiatry clinic". |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: not clearly mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "placebo which were capsules in the similar shape and packaging as vitamin D and probiotic" Judgement comment: No reference to how blinding was done or who provided the medication. The only mention to blinding is that the study is "double‐blind" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: No information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: The study addresses all of the primary outcomes prespecified in the Methods section and in trial that is registered. The drop‐outs were included with the reasons addressed. The drop‐out numbers (N = 4 of each group) is minimal and for similar reasons. The study includes all participants in the analysis, including those that dropped out, using intention‐to‐treat methods. |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: trial was retrospectively registered. |
Other sources of bias | Low risk | Quote: "The research grant provided by Research Deputy of Kashan University of Medical Sciences (KAUMS)." Judgement comment: we did not find any other source of bias |