Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5448
Source ID: NCT04377399
Associated Drug: Vitamin D
Title: High vs Low Dose Vitamin D in Patients With Diabetic Peripheral Neuropathy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Type 2|Diabetic Neuropathies|Vitamin D Deficiency
Interventions: DRUG: Vitamin D
Outcome Measures: Primary: Microcirculation, Assessment of microcirculatory changes using laser doppler, Baseline and 24 weeks | Secondary: Interleukins, Serum interleukins (IL) will be determined by enzyme-linked immunosorbent assay (Bio-Rad 680 Microplate Reader, USA) using the appropriate sets of reagents for enzyme immunoassay to determine the concentration of IL-1β (reference values 0-5.0 pg/ml), IL-6 (reference values 0-7.0 pg/ml), IL-10 (reference values 0-9.1 pg/ml), (Vector-Best, Novosibirsk, Russia) compared from baseline, Baseline and 24 weeks|Tumor necrosis factor-α (TNFα), Tumor necrosis factor-α (TNFα) will be determined by enzyme-linked immunosorbent assay (Bio-Rad 680 Microplate Reader, USA) using the appropriate sets of reagents for enzyme immunoassay to determine the concentration of TNFα (reference values 0-8.21 pg/ml) (Vector-Best, Novosibirsk, Russia), Baseline and 24 weeks|Neuropathy disability score, Using standard scoring systems and questionnaires. Scoring is: Neuropathy disability score (0-10),, Baseline and 24 weeks|Pain score, Patients will be asked to score pain on a visual analog scale 0-10 with 10 being the worst pain ever, Baseline and 24 weeks|Neuropathic symptom score, This will be scored using standard questionnaire 0-9, Baseline and 24 weeks
Sponsor/Collaborators: Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | Collaborators: Tameside Hospital NHS Foundation Trust
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 68
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-01-10
Completion Date: 2020-01-25
Results First Posted:
Last Update Posted: 2020-05-06
Locations: Almazov National Medical Research Centre, Saint Petersburg, 197143, Russian Federation
URL: https://clinicaltrials.gov/show/NCT04377399