View older revisions Content changed at 2019-09-15, 1398/06/24

Protocol summary

Study aim
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.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Clinical symptom (primary outcomes), and metabolic profiles (secondary outcome) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
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
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:
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
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
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
Province
Isfehan
Postal code
8814187159
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
Fatemeh Sadat Ghoreishi
Street address
Ghotbe Ravandi Boulevard, Kargarnejad hospital, Psychiatry clinic, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Fax
+98 31 5554 0036
Email
dr.zoghoreishi@yahoo.com
Web page address
http://kargarnejad.kaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

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
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
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
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
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
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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