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Investigating the effect of vitamin B12 on the neuropathy of diabetic patients

Protocol summary

Study aim
Determining the effect of vitamin B12 on neuropathy in diabetic patients referred to Razi Birjand Hospital in 2024
Design
clinical trial with an intervention group, with a parallel group; Double blind, randomized
Settings and conduct
This study is conducted in Razi Birjand Hospital, South Khorasan Province. 80 patients with type 2 diabetes were randomly divided into two intervention or control groups (A-B). At the beginning and end of the study, the average score of pain, symptoms and severity of involvement of neuropathy is evaluated. ​
Participants/Inclusion and exclusion criteria
Our study population will be the number of 80 patients diagnosed with type 2 diabetes based on the criteria of the American Diabetes Association, referring to Razi Birjand Outpatient Neurology Clinic in 2024. Inclusion criteria: consent of patients to enter the study, suffering from diabetes for more than one year and exclusion criteria include: having an underlying disease such as myositis, connective tissue and joint disease, limb amputation, autoimmune disease, severe osteoarthritis, malignancy, fibromyalgia, failure kidney and liver, patients with ESRD, prolonged diabetes, vertebral discopathy, anemia, hypothyroidism and drug use.
Intervention groups
The intervention groups are as follows: Control group: receiving routine neuropathy drugs and intervention group: group receiving routine drugs + vitamin B12 1000 micrograms daily. The patients took the above medicines for 3 months and before and after the intervention (3 months after taking the medicine) the considered parameters are evaluated.
Main outcome variables
Average pain score, neuropathy symptoms and severity of neuropathy involvement based on muscle nerve strip

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N24
Registration date: 2024-03-02, 1402/12/12
Registration timing: registered_while_recruiting

Last update: 2024-03-02, 1402/12/12
Update count: 0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vitamin B12 on the neuropathy of diabetic patients
Public title
Evaluation of the effect of vitamin B12 on neuropathy in diabetic patients of Razi Hospital in Birjand in 2023
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction to enter the study Having diabetes for more than a year
Exclusion criteria:
Having an underlying disease such as myositis Having connective tissue and joint disease Limb amputation Having autoimmune disease Having severe osteoarthritis Malignancy Having fibromyalgia Having kidney and liver failure Patients with ESRD Prolonged diabetes Having vertebral discopathy Having anemia Having hypothyroidism Drug use
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The placement of people in each group will be simple random and in a block method, in one of two control groups A: receiving routine neuropathy drugs and intervention group B: group receiving routine drugs + vitamin B12 divided daily 1000 micrograms will be One of these blocks will be randomly selected using the lottery method and the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well. This will be done by the secretary.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome evaluator: The study leader (4th year neurology assistant) examines the symptoms of neuropathy at the beginning and end of the study without knowing the patients' placement in the drug group. The data analyst also does not know the placement of the patients and the type of drug they will receive, they will be blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.BUMS.REC.1402.343

Health conditions studied

1

Description of health condition studied
Diabetic neuropathy
ICD-10 code
E08.43
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy

Primary outcomes

1

Description
Pain
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Using the audio-visual pain scale questionnaire

2

Description
Symptoms and severity of neuropathy
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
By Using Nerve conduction velocity

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Recipients of routine neuropathy drugs, patients who have taken the above drugs for 3 months, and before and after the intervention (3 months after taking the drug), the relevant parameters are evaluated.
Category
Treatment - Drugs

2

Description
Intervention group: The second intervention group: the group receiving routine drugs + vitamin B12 in the form of 1000 micrograms daily, the patients took the above drugs for 3 months, and before and after the intervention (3 months after taking the drug), the relevant parameters were evaluated.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Mesam Javadi
Street address
Neurology Clinic of Razi Hospital,Ghaffari Blvd, Iran- South Khorasan- Birjand,.
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3136 6000
Email
razihospital@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Masoud Yosefi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Meysam Javadi
Position
Asistant Neurology
Latest degree
Ph.D.
Other areas of specialty/work
Neurology
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3238 1500
Email
oabstudent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Hamidreza Riasee
Position
Member of the Faculty
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3236 6000
Email
oabstudent@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 915 104 6738
Email
zabihullahmohaghegh@gmail.com

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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