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IRCT2017072333551N2 IRCT 2017-07-31 Vice chancellor for research, Kashan University of Medical Sciences Effect of supplementation in treatment of schizophrenia patients Clinical trial of the effect of combined probiotic and vitamin D supplementation compared with the placebo on Clinical symptom and metabolic profiles in schizophrenia patients 2017-05-04 anticipated 60 Complete https://irct.ir/trial/25842 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group, Blinding description: Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff. 2 Schizophrenia. Intervention 1: Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally. Intervention 2: Control group: Probiotic and vitamin D placebos capsule (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Diagnosed with schizophrenia using DSM-IV-TR criteria PANSS score of 55 or greater Treated with chlorpromazine (300–1000mg/day, except clozapine) and agents anti-cholinergic (Trihexyphenidyl, 4–8 mg/day) during the last 6 months Aged 25–65 years old Disease duration of at least two years 25 years 65 years Both Mental retardation Substance or alcohol addiction (except caffeine or nicotine) with in 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) Under treatment with lithium, carbamazepine and sodium valproic acid Existing chronic and acute medical illness Lactation or pregnancy The use of anti-depressants including MAO, TCA, SSRI in the last 6 months F20 Schizophrenia Treatment - Drugs Treatment - Drugs Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally. Control group: Probiotic and vitamin D placebos capsule (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally. Positive and Negative Syndrome Scale(PANSS). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Clinical Examination. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Vice chancellor for research, Kashan University of Medical Sciences Approved 2017-05-03 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)