Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D and Painful Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05080530
Recruitment Status : Not yet recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Abdul Basit, Baqai Institute of Diabetology and Endocrinology

Tracking Information
First Submitted Date  ICMJE September 29, 2021
First Posted Date  ICMJE October 15, 2021
Last Update Posted Date October 15, 2021
Estimated Study Start Date  ICMJE November 1, 2021
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2021)
  • Change from baseline in DN4 score. [ Time Frame: 3 months ]
    The change will be observed with the help of neuropathic pain assessment questionnaire.
  • Change from baseline in serum HbA1c. [ Time Frame: 3 months ]
    The change will be observed in the serum values of glycated hemoglobin at the end point after the administration of vitamin D.
  • Change from baseline in serum vitamin D. [ Time Frame: 3 months ]
    The cholecalciferol (Vitamin D) level in serum will be observed at the end point after the administration of vitamin D.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Painful Diabetic Neuropathy
Official Title  ICMJE Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
Brief Summary

The main objective of this study is to evaluate the effect of vitamin D3 on diabetic individual with painful neuropathy in a tertiary healthcare.

The people with diabetes (type 1 and type 2) who have a Douleur Neuropathique 4 (DN4) score ≥4 will be considered eligible in this prospective study. Their serum samples will be subjected to pre-and post-biochemical screening of serum 25 (OH) D and HbA1c. The individual having Vitamin D insufficiency and deficiency will be administered a single dose of oral Vitamin D3 (Soft Gel capsule 200,000 IU), and follow-up for post-biochemical screening after 3 months.

Detailed Description

Painful diabetic neuropathy (PDN) is the most common diabetic complication in patients who have had diabetes mellitus for a long time. Diabetic peripheral neuropathy is the common cause of neuropathy globally. About 50-60% of individuals with long-term diabetes develop diabetic neuropathy. Several recent observational studies in diabetic individuals have provided a correlation between vitamin D insufficiency and diabetes. Despite the fact that the pathogenesis of diabetic neuropathy is complex, recent investigations revealed that deficiency of vitamin D is an important factor in the development of diabetic neuropathy. Also, vitamin D supplementation was found to be effective in treating neuropathic pain and preventing neuronal degeneration.

Aims and Objectives:

The assessment of the effect of single-dose, oral vitamin D in patients with painful diabetic neuropathy.

Materials and Methods:

Study Drug: Oral cholecalciferol (Vitamin D3 capsule 200,000 IU).

A single oral dose of 200000 IU vitamin D will be administered in people with diabetic neuropathy, and the effect will be observed after 3 months.

  • Sample size = 216 type 1 and 2 diabetic subjects
  • Recruitment time = 4 months
  • Treatment duration = 3 months

Ethical Approval:

The ethical approval for this study will be taken from the Institutional Review Board (IRB) of Baqai Institute of Diabetology and Endocrinology (BIDE)

Study Area and Duration:

This study is going to be conducted from October 2021 to March 2022 in the outpatient department (OPD) of BIDE.

Data Analysis and Statistics:

The primary analysis will compare the change from baseline. Comparisons within each treatment group across time will also be considered. The analysis will be performed with the Statistical Package for the Social Sciences (SPSS).

Assessment during the Treatment Period:

  • Change from baseline in DN4
  • Change from baseline in serum 25 (OH) D,
  • Change from baseline in HbA1c
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Painful Diabetic Neuropathy
Intervention  ICMJE Drug: Cholecalciferol
Effect of Vitamin D on diabetic neuropathy symptoms
Other Name: Sunny D™ (Vitamin D3) Softgel Capsule
Study Arms  ICMJE
  • No Intervention: 1. Normal Vit D (> 30ng/mL)
    Follow-up after 3 months with standard treatment
  • Experimental: 2. Insufficient Vit D (20-30ng/mL)
    single oral dose capsule 200,000 IU of Cholecalciferol
    Intervention: Drug: Cholecalciferol
  • No Intervention: 3. Insufficient Vit D (20-30ng/mL)
    Follow-up after 3 months with standard treatment
  • Experimental: 4. Deficient Vit D
    single oral dose capsule 200,000 IU of Cholecalciferol
    Intervention: Drug: Cholecalciferol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2021)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Insulin dependent diabetes
  • Insulin independent diabetes
  • Age range between 25 to 80 years
  • Glycated hemoglobin (HbA1c) level must be ≤11%
  • Apparently no symptoms of Vitamin D Deficiency

Exclusion Criteria:

  • History of hyperparathyroidism
  • Pregnant women
  • Lactating mothers
  • History for rickets and osteomalacia
  • On Vitamin D supplementation
  • On Multivitamin
  • On anti-epileptics
  • On steroids
  • On bisphosphonates
  • On oral contraceptives
  • Subjects who refuse to participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Abdul Basit, Professor 009221-36707179 research@bide.edu.pk
Contact: Asher Fawwad, Professor 009221-36707179 asherfawwad@bide.edu.pk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05080530
Other Study ID Numbers  ICMJE BIDE-216D/2021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abdul Basit, Baqai Institute of Diabetology and Endocrinology
Study Sponsor  ICMJE Baqai Institute of Diabetology and Endocrinology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abdul Basit, Director Baqai Institute of Diabetology and Endocrinology (BIDE)
PRS Account Baqai Institute of Diabetology and Endocrinology
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP