Studying the effect of vitamin D intake on the severity of diabetic neuropathic pain
Determining the relationship between vitamin D levels and the severity of neuropathic pain in patients with vitamin D deficiency and diabetic neuropathy after using vitamin D supplementation
Confirmation of diabetic neuropathy by EMG-NCV
Design
Clinical trial in the intervention group before and after treatment, double-blind, phase 2 on 38 patients.
Settings and conduct
Type 2 diabetic patients who referred to Dezful University of Medical Sciences with complaints of diabetic neuropathy symptoms were selected. After Michigan screening, vitamin D levels were measured. Neuropathy in those with vitamin D levels less than 30 was confirmed by nerve and muscle electromyography. Patients received vitamin D supplementation based on vitamin D levels. After treatment, vitamin D levels were measured and Michigan screening was performed. The procedures were performed with the patients' informed consent and during the study, the patients and the evaluator were unaware of the purpose of the study.
Participants/Inclusion and exclusion criteria
Type 2 diabetes
Presence of diabetic neuropathy
Vitamin D level less than 30
No history of spondylopathy or severe arteriovenous vascular disease
No diseases affecting vitamin D metabolism (liver disease, kidney failure)
Intervention groups
First, the patients' history, vitamin D level measurement, and Michigan screening were performed. Then, muscle electromyography was performed to confirm diabetic neuropathy. Based on the vitamin D level, the patients were treated with 50,000 IU vitamin D tablets once a week for a treatment period of 4 to 12 weeks. After treatment, vitamin D level measurement and Michigan screening were performed.
Main outcome variables
Improving the severity of diabetic neuropathy pain in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251102067854N1
Registration date:2025-11-23, 1404/09/02
Registration timing:retrospective
Last update:2025-11-23, 1404/09/02
Update count:0
Registration date
2025-11-23, 1404/09/02
Registrant information
Name
Malihe Moeinjozan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4222 2307
Email address
malihemoeinjozan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
2024-12-21, 1403/10/01
Actual recruitment end date
2025-05-22, 1404/03/01
Trial completion date
2025-05-22, 1404/03/01
Scientific title
Investigating the effect of vitamin D consumption on the severity of neuropathic pain in diabetic patients
Public title
The effect of vitamin D consumption on the severity of diabetic neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 2 diabetes•
Possession of a medical record at the Dezful Diabetes Research Center
Willingness to participate in the study
Presence of diabetic neuropathy
People with low vitamin D levels (less than 30).
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
38
Actual sample size reached:
38
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
Dezful University of Medical Sciences
Street address
Dezful Ganjovian Hospital
City
Dezful
Province
Khouzestan
Postal code
6461669969
Approval date
2024-10-16, 1403/07/25
Ethics committee reference number
IR.DUMS.REC.1403.057
Health conditions studied
1
Description of health condition studied
The severity of diabetic neuropathy pain
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified