Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706377
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2021-01-09
Brief Title:
Vitamin B12 Supplementation in Diabetic Neuropathy
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
Vitamin B12 Supplementation in Diabetic Neuropathy 1-year Double Blind Randomized Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective double-blind placebo-controlled trial aims to investigate the safety and efficacy of oral dispersible tablet of vitamin B12 for 1 year in 90 patients with diabetes mellitus type 2 and neuropathy
Detailed Description:
In this prospective double-blind placebo-controlled trial 90 patients with type 2 diabetes on metformin treatment for at least four years and both peripheral and autonomic diabetic neuropathy were randomized to an active treatment group n44 receiving B12 and a control group n46 receiving placebo All patients had B12 levels less than 400 pmolL Subjects underwent measurement of sural nerve conduction velocity and amplitude vibration perception threshold and performed cardiovascular autonomic reflex tests CARTs Mean Circular Resultant Valsalva test postural index and orthostatic hypotension Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet The Michigan Neuropathy Screening Instrument Questionnaire and Examination and questionnaires to evaluate quality of life and level of pain were also used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None