Outcome of Large-fiber Neuropathy after Vitamin D Treatment in Patient with Diabetes Neuropathy and Vitamin D Insufficiency: A Randomized Controlled Trial

Phase 3

Recruiting

• Conditions: patients with diabetes neuropathy who had symptoms of large-fiber neuropathy and vitamin D insufficiency; diabetes neuropathy, large-fiber neuropathy, vitamin D insufficiency

• Registration Number: TCTR20240715008
• Lead Sponsor: Thai Red Cross Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Last Update Posted: 19 August 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 62

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Neuropathy Disability Score 12 weeks after end of the intervention vibration perception score and Achilles reflex score of modified Neuropathy Disability Score

Secondary Outcome Measures

Name	Time	Method
erve 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