patients with diabetes neuropathy who had symptoms of large-fiber neuropathy and vitamin D insufficiency diabetes neuropathy, large-fiber neuropathy, vitamin D insufficiency
Conditions
Interventions
calciferol (20000 IU) 3 caps oral weekly for 12 weeks,Matching placebo 3 caps oral weekly for 12 weeks
Active Comparator Drug,Placebo Comparator Drug
calciferol,placebo
Sponsors
Thai Red Cross Society
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age over 18 years. 2. Patients diagnosed with diabetes mellitus. 3. Patients had one or more symptoms consistent with large fiber neuropathy from diabetes, such as symmetric numbness in both feet, abnormal vibration test results using a tuning fork on the toe joints, reduced ankle reflexes, loss of protective sensation as measured by a 10 g monofilament test, or abnormal proprioception. 4. Patients without symptoms of painful small fiber neuropathy, such as sharp pain, burning, electrical shocks, or stabbing sensations. 5. Patients with blood vitamin D levels less than 30 ng/mL at the screening visit. 6. Patients who consent to participate in the research study.
Exclusion criteria
Exclusion criteria: 1. Patients with vitamin B12 levels below 400 pg/mL. 2. Patients with hypothyroidism (FT4 below normal or TSH > 10 uIU/mL). 3. Patients with chronic kidney disease and eGFR (Thai equation) <30 mL/min/1.73 m2. 4. Patients with HbA1c levels > 10% 5. Patients with abnormalities due to vitamin D deficiency, such as fractures after minor trauma or symptoms of hypocalcemia. 6. Patients with infectious diseases such as symptomatic HIV, tuberculosis, or leprosy. 7. Patients receiving Highly Active Antiretroviral Therapy (HAART). 8. Patients with active cancer or those who have undergone chemotherapy. 9. Patients with systemic diseases such as vasculitis or amyloidosis. 10. Patients with other neurological disorders such as chronic inflammatory demyelinating neuropathy, hemiparesis, or hereditary neurological disorders. 11. Patients with chronic alcoholism or substance abuse. 12. Patients taking medications affecting the nervous system, such as alpha-lipoic acid. 13. Patients taking medications affecting vitamin D metabolism (phenytoin, phenobarbital, rifampicin). 14. Patients taking active forms of vitamin D (alfacalcidol or calcitriol). 15. Patients participating in other studies involving medications affecting the peripheral nervous system. 16. Pregnant or breastfeeding individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Neuropathy Disability Score 12 weeks after end of the intervention vibration perception score and Achilles reflex score of modified Neuropathy Disability Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Nerve conduction study 12 weeks after end of the intervention Nerve conduction study of sural nerve (non dominant leg),Vibration detection threshold 12 weeks after end of the intervention Vibration quantitative sensory testing (non dominant leg),Vibration detection threshold 12 weeks after end of the intervention Rydel Seiffer tuning fork (non dominant leg),Visual analog scale of neuropathic symptom 12 weeks after end of the intervention Patient report degree of neuropathic symptom on visual analog scale,VitaminD level 12 weeks after end of the intervention result of vitamin D level before and after treatment,Association between vitamin D and neuropathic symptom 12 weeks after end of the intervention vitamin D level, modified Neuropathy Disability Score | — |
Countries
Thailand
Contacts
Public ContactPatinut Buranasupkajorn
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed