Protocol summary
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Study aim
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The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on Clinical symptom and metabolic profiles in schizophrenia patients.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 60 patients with schizophrenia of eligible and referred to Karganejad hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diagnosed with schizophrenia using DSM-IV-TR criteria, 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. Exclusion criteria: 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.
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Intervention groups
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Intervention: Patients will be assigned into two groups to receive combined probiotic and vitamin D (n=30) or placebo (n=30). Probiotic, vitamin D and placebos capsules are similar in shape and size.
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Main outcome variables
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Clinical symptom (primary outcomes), and metabolic profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017072333551N2
Registration date:
2017-07-31, 1396/05/09
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2017-07-31, 1396/05/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-05-04, 1396/02/14
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Expected recruitment end date
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2017-06-04, 1396/03/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of supplementation in treatment of schizophrenia patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 25 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-05-03, 1396/02/13
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Ethics committee reference number
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IR.Kaums.REC.1396.10
Health conditions studied
1
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Description of health condition studied
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Schizophrenia
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ICD-10 code
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F20
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ICD-10 code description
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Schizophrenia
Primary outcomes
1
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Description
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Positive and Negative Syndrome Scale(PANSS)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Clinical Examination
Secondary outcomes
1
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
3
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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HDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
7
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Description
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Total antioxidant
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available