Vitamin B12 Deficiency Anemia Clinical Trials

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A 12-Week Double-blind Randomized Controlled Study; Comparing the Efficacy of Benfotiamine and Vitamin b1-6-12 in Alleviating Numbness, Sensory Neuropathy Symptoms and Pain in Patients With Diabetic Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this clinical trial is to compare the efficacy of benfotiamine with vitamin B1-6-12 in reducing sensory neuropathy symptoms, numbness and pain in patients with diabetic peripheral neuropathy. The main questions this study aims to answer are: * Does benfotiamine reduce overall sensory neuropathy symptoms more effectively than vitamin B1-6-12? * Does benfotiamine reduce numbness more effectively than vitamin B1-6-12? * Does benfotiamine reduce pain more effectively than vitamin B1-6-12? Researchers will compare benfotiamine with vitamin B1-6-12 in a double-blind study. Both treatments will be manufactured as visually identical study medications to maintain blinding. The study will evaluate whether benfotiamine provides greater improvement in sensory neuropathy symptoms, numbness, and pain than vitamin B1-6-12 in patients with diabetic peripheral neuropathy. Participants will: * undergo screening for vitamin B12 deficiency before enrollment. Patients with vitamin B12 deficiency will not be eligible for participation. * randomly assigned to receive either benfotiamine or vitamin B1-6-12, taken orally twice daily for 3 months. * attend two on-site clinic visits (baseline and the end of the study) and complete two telephone follow-up assessments during the study. * continue their usual medications throughout the study, provided that no new neuropathic pain medications are initiated and the dose of existing neuropathic pain medications remains unchanged.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years.

• Diagnosis of diabetic peripheral neuropathy confirmed by a physician based on the following ICD-10 codes: E11.42: Type 2 diabetes mellitus with diabetic polyneuropathy; or E11: Type 2 diabetes mellitus, combined with either:

⁃ M79.2: Neuralgia and neuritis, unspecified; or G62.9: Polyneuropathy, unspecified.

• Presence of sensory neuropathy symptoms assessed using the Neuropathy Total Symptom Score-6 (NTSS-6), with: Total NTSS-6 score ≥1; and Numbness symptom score (NTSS-6 item 6) ≥1.

• No evidence of vitamin B12 deficiency, defined as a serum vitamin B12 level ≥200 pg/mL (148 pmol/L).

• provide informed consent and participate in the study.

Locations
Other Locations
Thailand
Thammasat University Hospital
RECRUITING
Pathumthani
Contact Information
Primary
Supitcha Lamlertpanya
supicha.lam0901@gmail.com
+66972723880
Backup
Arom Jedsadayanmata
aromj@tu.ac.th
+6629869214
Time Frame
Start Date: 2026-07-14
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 66
Treatments
Experimental: Benfotiamine
Parcipitant in this arm will recieve benfotiamine 300 mg per day
Active_comparator: Vitamin B 1-6-12
Parcipitant in this arm will recieve Vitamin B1-6-12 combined pill (total B1 200 mg, B6 10 mg and B12 130 mcg per day)
Sponsors
Leads: Thammasat University
Collaborators: Wörwag Pharma GmbH & Co. KG

This content was sourced from clinicaltrials.gov