Vitamin D and Painful Diabetic Neuropathy

NCT ID: NCT05080530

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-29
• Study Completion Date: 2022-08-20

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

Conditions

Painful Diabetic Neuropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. Normal Vit D (> 30ng/mL)

Follow-up after 3 months with standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

2. Insufficient Vit D (20-30ng/mL)

single oral dose capsule 200,000 IU of Cholecalciferol

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

Effect of Vitamin D on diabetic neuropathy symptoms

3. Insufficient Vit D (20-30ng/mL)

Follow-up after 3 months with standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

4. Deficient Vit D

single oral dose capsule 200,000 IU of Cholecalciferol

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

Effect of Vitamin D on diabetic neuropathy symptoms

Interventions

Cholecalciferol

Effect of Vitamin D on diabetic neuropathy symptoms

Intervention Type: DRUG

Other Intervention Names

Sunny D™ (Vitamin D3) Softgel Capsule

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scotmann Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Baqai Institute of Diabetology and Endocrinology

OTHER

Sponsor Role: lead

Responsible Party

Abdul Basit

Professor of Medicine, and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdul Basit, Director

Role: PRINCIPAL_INVESTIGATOR

Baqai Institute of Diabetology and Endocrinology (BIDE)

Locations

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Abdul Basit, Professor

Role: CONTACT

research@bide.edu.pk

009221-36707179

Asher Fawwad, Professor

Role: CONTACT

asherfawwad@bide.edu.pk

009221-36707179

Facility Contacts

Abdul Basit, Professor

Role: primary

research@bide.edu.pk

009221-36707179

Asher Fawwad, Professor

Role: backup

asherfawwad@bide.edu.pk

009221-36707179

Other Identifiers

BIDE-216D/2021

Identifier Type: -

Identifier Source: org_study_id