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
Objective: 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. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with schizophrenia aged 18 to 60 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: 50 patients with schizophrenia of eligible and referred to Karganejad hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned into two groups to receive combined probiotic and vitamin D (n=25) or placebo (n=25). Probiotic, vitamin D and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks. Outcomes: Clinical symptom (primary outcomes), and metabolic profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072333551N2
Registration date:2017-07-31, 1396/05/09
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-07-31, 1396/05/09
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-05-04, 1396/02/14
Expected recruitment end date
2017-06-04, 1396/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of supplementation in treatment of schizophrenia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with schizophrenia; aged 18 to 60 years. Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.Kaums.REC.1396.10
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive and Negative Syndrome Scale(PANSS)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Clinical Examination
Secondary outcomes
1
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
7
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad Hospital
Full name of responsible person
Zatollah Asemi
Street address
5th of Qotb –e Ravandi Blvd, Kargarnejad hospital, Kashan, IRAN
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)