Vitamin D and Painful Diabetic Neuropathy

Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy

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.

Study Overview

• Status: Recruiting
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Drug: Cholecalciferol

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: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdul Basit, Professor; Phone Number: 009221-36707179; Email: research@bide.edu.pk
• Study Contact Backup: Name: Asher Fawwad, Professor; Phone Number: 009221-36707179; Email: asherfawwad@bide.edu.pk

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74600
      • Recruiting
      • Baqai Institute of Diabetology and Endocrinology (BIDE)
      • Contact: Abdul Basit, Professor; Phone Number: 009221-36707179; Email: research@bide.edu.pk
      • Contact: Asher Fawwad, Professor; Phone Number: 009221-36707179; Email: asherfawwad@bide.edu.pk
      • Principal Investigator: Abdul Basit, Director

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Insulin dependent diabetes
• Insulin independent diabetes
• Age range between 25 to 80 years
• Glycated hemoglobin (HbA1c) level must be ≥ 6.5%
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Cholecalciferol; Effect of Vitamin D on diabetic neuropathy symptoms; Other Names: Sunny D™ (Vitamin D3) Softgel Capsule
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	Drug: Cholecalciferol; Effect of Vitamin D on diabetic neuropathy symptoms; Other Names: Sunny D™ (Vitamin D3) Softgel Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in DN4 score.	The change will be observed with the help of neuropathic pain assessment questionnaire.	3 months
Change from baseline in serum HbA1c.	The change will be observed in the serum values of glycated hemoglobin at the end point after the administration of vitamin D.	3 months
Change from baseline in serum vitamin D.	The cholecalciferol (Vitamin D) level in serum will be observed at the end point after the administration of vitamin D.	3 months

Collaborators and Investigators

• Sponsor: Baqai Institute of Diabetology and Endocrinology
• Collaborators: Scotmann Pharmaceuticals
• Investigators: Principal Investigator: Abdul Basit, Director, Baqai Institute of Diabetology and Endocrinology (BIDE)

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Anticipated): August 20, 2022
• Study Completion (Anticipated): August 20, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: BIDE-216D/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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