This was an experimental doubleblind randomized controlled trial (RCT) to compare the effectiveness of 50000 units of vitamin D orally/weekly for 12 weeks and control group on diabetic neuropathy. 60 patients (ages 40 to 65 years old)
With diagnosis of diabetic neuropathy (through physical examination and earning more than 4 points from Michigan script and not taking supplemental medications and vitamin D in the last 6 months, lack of kidney and liver failure, arthritic inflammatory diseases, rheumatoid arthritis, hyperthyroidism , Malnutrition, and not pregnant are selected and randomly divided into two groups of study and control.
The study group receives 50,000 units of vitamin D in 12 weeks orally. In the control group, patients receive a placebo.
Before the start of the study, before 12 weeks, the severity of neuropathy is measured through the Michigan questionnaire and a physical examination. And again, upon termination of the drug use, the patient is examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102325266N2
Registration date:2017-11-08, 1396/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Akram Ghadiri Anari
Name of organization / entity
Diabetes Research Center
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0226
Email address
ghadiriam@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, YazdUniversity of Medical Sciences
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of 50000 units of vitamin D orally/weekly for 12 weeks and control group on diabetic neuropathy- clinical trial
Public title
The effectiveness of vitamin D on diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Type 2 diabetes, aged 40-60 years old, having a medical record at the Yazd diabetes research center, willingness to participate in the study, diagnosis of diabetic neuropathy through physical examination and obtaining a score of more than 4 from the Michigan Neuropathy Screening Questionnaire Instrument (MNSI)
Exclusion Criteria:
Inability to follow the patient (life in the city, illness (end stage, absence of leg pulp, lower limb, pregnancy, acute and severe pain requiring injection of lidocaine, current consumers supplementing vitamin D and calcium or multivitamin, taking Injection of vitamin D over the past 6 months, the presence of the following disorders according to the case: kidney failure, liver failure, arthritic inflammatory diseases, rheumatoid arthritis, hyperparathyroidism, alcoholism, malnutrition, consumers of neuropathic inducers
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Yazd University of Medical Science
Street address
Talar honar alley, Bahonar square, Yazd, Iran
City
Yazd
Postal code
8916978477
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.SSU.REC.1396.71
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
The severity of diabetic neuropathy
Timepoint
Before the intervention, After the intervention
Method of measurement
Michigan Neuropathy Screening Instrument (MNSI)
2
Description
Vitamin D
Timepoint
Before the intervention, After the intervention
Method of measurement
Blood Test
Secondary outcomes
1
Description
HbA1C
Timepoint
Before the intervention, After the intervention
Method of measurement
Blood Test
Intervention groups
1
Description
A group of subjects receive 50,000 units of vitamin D per week per week for 12 weeks during the intervention period.
Category
Treatment - Drugs
2
Description
The control group receive during the intervention of perl weekly placebo at the same time as the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabete Research Center
Full name of responsible person
Masoud Rahmanian
Street address
Talar Honar alley, Bahonar square, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of University of Medical Sciences and Health Services, Yazd
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
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 of University of Medical Sciences and Health Services, Yazd
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
Yazd University of Medical Science
Full name of responsible person
Marzieh Abutorabi
Position
Assistant Professorو Neurologist
Other areas of specialty/work
Street address
Iran, Yazd, Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 3728 0226
Fax
Email
marzie.ab@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Science
Full name of responsible person
Akram Ghadirianari
Position
Associate Professor Endocrinologist
Other areas of specialty/work
Street address
Talar honar alley, Bahonar square, Yazd, Iran
City
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Fax
Email
ghadiriam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Science
Full name of responsible person
Fariba Sepehri
Position
Researcher, MA
Other areas of specialty/work
Street address
City
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Fax
Email
sepehri_f66@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)