Evaluation of effects of vitamin B12 on the serum levels of pro-inflammatory cytokines in the patients with Alzheimer with and without behavioral disorders
The main aim of this study is to evaluate administration of Cobalamin on the serum levels of pro-inflammatory cytokines in the Alzheimeric patients with psychotic symptoms. Alzheimer diagnosis in patients were achieved based on Diagnostic and Statistical Manual of Mental Disorders criteria by history ,clinical examinations, Scan of the Brain , Magnetic resonance imaging and laboratory results combined with mini mental state examination score less than 23. The behavior disorders of the patients were measured using the brief psychiatric rating scale score. Patients suffering from Alzheimer were randomly divided by table of random numbers into four 20-member groups. For elderly in groups 1 and 2, quetiapine and risperidone were prescribed separately, respectively. The other groups are received risperidone or quetiapine combined with a Cobalamin 500 mg daily. Patient's behavior and pain response to treatment was assessed before treatment and after 2 and 8 weeks of study by using the brief psychiatric rating scale test and visual analogue scale for pain and clinical global improvement. ELISA technique will be used for evaluation of serum levels of the cytokines before and after treatment.
General information
Acronym
alzheimer
IRCT registration information
IRCT registration number:IRCT2015111625067N1
Registration date:2016-05-14, 1395/02/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Fattemeh Hosieni
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34258497
Email address
hossini1389@yahoo.com
Recruitment status
Recruitment complete
Funding source
University of Rafsanjan Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of vitamin B12 on the serum levels of pro-inflammatory cytokines in the patients with Alzheimer with and without behavioral disorders
Public title
Serum level of inflammatory cytokines in Alzheimer's patients with behavioral disorders and behavioral disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria In this study is: (Alzheimer diagnosis in elderly patients is carried out on basis of clinical interviews; DSM IV diagnosis criteria; medical history; clinical examinations; MRI and brain CT scan results and the mini mental state examination score; Patients who have mini mental score above than are studied; patient with Brief Psychiatric Rating Scale score 30-70)
Exclusion criteria (Patients who were taking anti-psychotic medication; has schizophrenia symptoms; preliminary psychotic disorders; delirium; psychoses followed by drug or medication take; Other medical background disorders like B12 deficiency and hypothyroidism; Patients needed to be hospitalized; Patients posed to suicide commitment risk; Other causes of dementia like brain tumors; strokes; normal pressure hydrocephalus; Underlying medical conditions; that may cause behavioral or psychotic symptoms or delirium such as infection, medications with anticholinergic effects; corticosteroid use; or neurological insults is the first step in the decision-making process for treatment. In addition, the patients were discarded from the procedure if they need further medical intervention and other drugs according to their health status or families’ remark.
Age
From 64 years old to 84 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Rafsanjan University of Medical Sciences
Street address
Central Organization of Rafsanjan University of Medical Siences, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Postal code
7718796755
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.RUMS.REC.1394.234
Health conditions studied
1
Description of health condition studied
Alzheimer
ICD-10 code
G30
ICD-10 code description
Alzheimer disease
Primary outcomes
1
Description
Pain
Timepoint
2week,4week,8week
Method of measurement
Visual Analogue Scale For Pain Questionnaire
Secondary outcomes
1
Description
Psychiatric symptoms
Timepoint
Before treatment , 2 weeks and 8 weeks after treatment
Method of measurement
Brief Psychiatric Rating Scale Questionnaire
Intervention groups
1
Description
Group of Patients is treated randomly with quetiapine alone, 12.5 mgr in night and rise to 25 to 50 mg according to patient condition
Category
Treatment - Drugs
2
Description
Group of Patients is treated randomly with risperidone alone, 0.5 mgr in night and rise to 1 to 2 mg daily according to patient condition.
Category
Treatment - Drugs
3
Description
Group of Patients Divided into two groups, one group received quetiapine combined with a cobalamin 500 mg daily.
Category
Prevention
4
Description
Group risperidone of Patients Divided into two groups,second group received risperidone combined with a cobalamin 500 mg daily.
Category
Prevention
5
Description
Patients who take risperidone. another group received placebo with risperidone
Category
Placebo
6
Description
Patients who take quetiapine. another group received placebo with quetiapine.
Category
Placebo
7
Description
Serum levels of IL-6, IL-8 and TNF-α, as pro-inflammatory cytokines, in all participants will be evaluated using ELISA method in a serum samples. Serum samples were collected from a coagulated blood after centrifuge
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers In The City
Full name of responsible person
Ali Reza Vakilian
Street address
Rafsanjan University of Medical Sciences
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hamid Hakimi
Street address
Central Organization of Rafsanjan University of Medical Siences, RaRafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Grant name
Grant code / Reference number
1247
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Reza Vakilin
Position
Assistant professor of neurology
Other areas of specialty/work
Street address
Central Organization of Rafsanjan University of Medical Siences, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Postal code
7717933777
Phone
+98 34 3428 0090
Fax
+98 34280071
Email
alirezavakilian66@rums.ac.ir
Web page address
www.rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Vakillin
Position
Assistant Professor Of Neurology
Other areas of specialty/work
Street address
Central Organization of Rafsanjan University of Medical Siences, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Postal code
7717933777
Phone
+98 34 3428 0090
Fax
+98 34280071
Email
alirezavakilian7@gmail.com
Web page address
www.rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fattemeh Hosieni
Position
Nurse/MSc
Other areas of specialty/work
Street address
Rafsanjan University of Medical Siences, Ra Rafsanjan University of Medical Sciences, Rafsanjan, Iran
City
Rafsanjan
Postal code
7717933777
Phone
+98 34 3428 0090
Fax
+98 34280071
Email
hossini1389@yahoo.com
Web page address
www.rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)