Vitamin D Deficiency Clinical Trial
Official title:
High-dose Vitamin D Supplementation Reduces Inflammation and Improves Microcirculation in Patients With Diabetic Peripheral Neuropathy
Aim. To assess the effect of different doses of vitamin D supplementation on peripheral
neuropathy in patients with type 2 diabetes mellitus (T2DM).
68 patients with T2DM and peripheral neuropathy will be randomized into two treatment groups:
cholecalciferol 5,000 IU once/week and cholecalciferol 40,000 IU once/week orally for 24
weeks. Severity of neuropathy (neuropathy symptom score (NSS), neuropathy disability score
(NDS), visual analog scale (VAS)), body mass index (BMI), glycated hemoglobin (HbA1c),
25-hydroxycalciferol (25(OH)D), parathyroid hormone (PTH), serum interleukins (IL) 1β, 6 and
10, C-reactive protein, tumor necrosis factor α and microcirculation (MC) parameters assessed
before and after treatment. The initial and final indicators of the skin blood flow (M, σ,
Kv) and MC parameters after postural and occlusal tests by laser Doppler flowmetry (LDF).
Sixteen subjects without diabetes will represent the control group.
Status | Completed |
Enrollment | 68 |
Est. completion date | January 25, 2020 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - males and females with T2DM aged 18 to 65 years - diabetes duration =5 years, - HbA1c <9%, - stable hypoglycemic, - hypotensive and hypolipidemic therapy - neurological deficit 4 points and more according to the neuropathy disability score (NDS). Exclusion Criteria: - patients with type 1 diabetes - hypothyroidism - glomerular filtration rate (GFR) <45 ml/min/1.73 m2 - current and former smokers - obliterating atherosclerosis - diabetic foot or Charcot osteoarthropathy - inflammatory joint diseases - oncological diseases - ongoing infectious diseases or in the preceding four weeks - alcohol and drug addiction - history of ?12 deficiency - anemia or current therapy with vitamin B12 - regular use of glucocorticoids - vitamin D supplements - anticoagulants - antidepressants - tricyclic antidepressants - anticonvulsants - opiates - non-steroidal anti-inflammatory drugs - vasoprotective and microcirculation correctors - alpha lipoic acid - group B vitamins. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Almazov National Medical Research Centre | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | Tameside Hospital NHS Foundation Trust |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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-1ß (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 | |
Secondary | Tumor necrosis factor-a (TNFa) | Tumor necrosis factor-a (TNFa) 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 TNFa (reference values 0-8.21 pg/ml) (Vector-Best, Novosibirsk, Russia) | Baseline and 24 weeks | |
Secondary | Neuropathy disability score | Using standard scoring systems and questionnaires. Scoring is: Neuropathy disability score (0-10), | Baseline and 24 weeks | |
Secondary | 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 | |
Secondary | Neuropathic symptom score | This will be scored using standard questionnaire 0-9 | Baseline and 24 weeks |
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