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

NCT04377399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-05-06

No results posted yet for this study

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.

Conditions

  • Diabetes Type 2
  • Diabetic Neuropathies
  • Vitamin D Deficiency

Interventions

DRUG

Vitamin D

Patients will be randomised to receive either high dose vitamin D (40,000 IU weekly) or low dose vitamin D (5,000 IU weekly) for 24 weeks

Sponsors & Collaborators

  • Tameside Hospital NHS Foundation Trust

    collaborator OTHER

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    lead OTHER

Principal Investigators

  • Tatiana Karonova, PhD · Almazov National Medical Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2019-06-20
Completion
2020-01-25

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04377399 on ClinicalTrials.gov