The main purpose of this study is comparison of severity of diabetic neuropathy before and after vitamin D prescription and the possibility of vitamin D usage in treatment of diabetic neuropathy. In a clinical randomized trial; not blinded; without control among patients referred to diabetes clinic of Kermanshah university of medical sciences, 90 patients with painful diabetic neuropathy are selected randomly. All the patients have neuropathic pain for at least a month in accordance with the marked inclusion and exclusion criteria They have vitamin D deficiency (<30ng/ml), no drug history of vitamin D in one year ago, no history of calcium or omega-3 supplements or other effective drugs in vitamin D metabolism or use of other drugs to relief painful neuropathy in 3 last months, no history of diseases can change vitamin D metabolism. There are no other etiologies of neuropathy. They are treated with tab vitamin D 50000 IU once a week for 3 months. The severity of diabetic neuropathy is evaluated before and after the intervention (based on Toronto clinical score system).Then the results are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082014416N1
Registration date:2013-08-30, 1392/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-30, 1392/06/08
Registrant information
Name
Bahareh Fereidouni
Name of organization / entity
Kermanshah university of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6334
Email address
bahareh.fereidouni@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of vitamin D efficacy on prepheral neuropathy in diabetic patients
Public title
A study of vitamin D efficacy on neuropathy in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with diabetes mellitus; both genders; under anti hyperglycemic agents therapy; with diabetic peripheral neuropathy syptoms in the form of pain and paresthesia in rest for at least 1 month and have vitimin D deficiency (<30 ng/ml) and no drug history of vitimin D in one year ago. Neuropathy score in diabetic patients is based on TCSS criteria(6-19 scores)
Exclusion criteria: no consent or ability to participate in the study; drug history of calcium or omega; supplements in 3 last months; drug history of effective drugs in vitimin D metabolism (estrogen, calcitonin...); history of diseases can change vitimin D metabolism(renal and liver diseases, cancers or other endocrine disorders); other etiologies of neuropathy (renal impairment or Cr>2g/dl or GBS) or in examination have radiculopathy; use of other drugs to relief painful neuropathy such as TCA antidepressants, Gabapentin, pergabalin in 3 last months.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Street,Kermanshah
City
Kermanshah
Postal code
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
33683
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
G 63.2*
ICD-10 code description
Diabetic Polyneuropathy
Primary outcomes
1
Description
Severity of diabetic neuropathy
Timepoint
First day,3 months later(90th day)
Method of measurement
Toronto Clinical Score System(TCSS)
Secondary outcomes
empty
Intervention groups
1
Description
Tab Vitamin D 50000 IU once a week for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabet Clinic of Kermanshah University of Medical Science