Status:
COMPLETED
High vs Low Dose Vitamin D in Patients With Diabetic Peripheral Neuropathy
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Collaborating Sponsors:
Tameside Hospital NHS Foundation Trust
Conditions:
Diabetes Type 2
Diabetic Neuropathies
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 wi...
Detailed Description
It is well known that vitamin D deficiency along with type 2 diabetes mellitus (T2DM) is a modern pandemic. Development of microvascular complications in T2DM worsens both the prognosis and the patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04377399
Start Date
January 10 2018
End Date
January 25 2020
Last Update
May 6 2020
Active Locations (1)
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1
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197143