NCT04377399

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

1.4 years

First QC Date

April 29, 2020

Last Update Submit

May 5, 2020

Conditions

Diabetes Type 2Diabetic NeuropathiesVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Microcirculation

    Assessment of microcirculatory changes using laser doppler

    Baseline and 24 weeks

Secondary Outcomes (5)

  • Interleukins

    Baseline and 24 weeks

  • Tumor necrosis factor-α (TNFα)

    Baseline and 24 weeks

  • Neuropathy disability score

    Baseline and 24 weeks

  • Pain score

    Baseline and 24 weeks

  • Neuropathic symptom score

    Baseline and 24 weeks

Study Arms (2)

high dose

ACTIVE COMPARATOR

vitamin D (40,000 IU weekly) for 24 weeks

Drug: Vitamin D

Low dose

ACTIVE COMPARATOR

vitamin D (5,000 IU weekly) for 24 weeks

Drug: Vitamin D

Interventions

Vitamin DDRUG

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

Low dosehigh dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197143, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic NeuropathiesVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tatiana Karonova, PhD

    Almazov National Medical Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 6, 2020

Study Start

January 10, 2018

Primary Completion

June 20, 2019

Study Completion

January 25, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)