High vs Low Dose Vitamin D in Patients With Diabetic Peripheral Neuropathy

• Status: Completed
• Trial end date: 2020-01-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Collaborator: Tameside Hospital NHS Foundation Trust
• Treatments: Vitamin D

Criteria

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 В12 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.