Vitamin D and Painful Diabetic Neuropathy
Primary Purpose
Painful Diabetic Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Painful Diabetic Neuropathy
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
Sites / Locations
- Baqai Institute of Diabetology and Endocrinology (BIDE)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
No Intervention
Experimental
Arm Label
1. Normal Vit D (> 30ng/mL)
2. Insufficient Vit D (20-30ng/mL)
3. Insufficient Vit D (20-30ng/mL)
4. Deficient Vit D
Arm Description
Follow-up after 3 months with standard treatment
single oral dose capsule 200,000 IU of Cholecalciferol
Follow-up after 3 months with standard treatment
single oral dose capsule 200,000 IU of Cholecalciferol
Outcomes
Primary Outcome Measures
Change from baseline in DN4 score.
The change will be observed with the help of neuropathic pain assessment questionnaire.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05080530
First Posted
September 29, 2021
Last Updated
July 19, 2022
Sponsor
Baqai Institute of Diabetology and Endocrinology
Collaborators
Scotmann Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05080530
Brief Title
Vitamin D and Painful Diabetic Neuropathy
Official Title
Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Anticipated)
Study Completion Date
August 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqai Institute of Diabetology and Endocrinology
Collaborators
Scotmann Pharmaceuticals
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1. Normal Vit D (> 30ng/mL)
Arm Type
No Intervention
Arm Description
Follow-up after 3 months with standard treatment
Arm Title
2. Insufficient Vit D (20-30ng/mL)
Arm Type
Experimental
Arm Description
single oral dose capsule 200,000 IU of Cholecalciferol
Arm Title
3. Insufficient Vit D (20-30ng/mL)
Arm Type
No Intervention
Arm Description
Follow-up after 3 months with standard treatment
Arm Title
4. Deficient Vit D
Arm Type
Experimental
Arm Description
single oral dose capsule 200,000 IU of Cholecalciferol
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Sunny D™ (Vitamin D3) Softgel Capsule
Intervention Description
Effect of Vitamin D on diabetic neuropathy symptoms
Primary Outcome Measure Information:
Title
Change from baseline in DN4 score.
Description
The change will be observed with the help of neuropathic pain assessment questionnaire.
Time Frame
3 months
Title
Change from baseline in serum HbA1c.
Description
The change will be observed in the serum values of glycated hemoglobin at the end point after the administration of vitamin D.
Time Frame
3 months
Title
Change from baseline in serum vitamin D.
Description
The cholecalciferol (Vitamin D) level in serum will be observed at the end point after the administration of vitamin D.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdul Basit, Professor
Phone
009221-36707179
Email
research@bide.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Asher Fawwad, Professor
Phone
009221-36707179
Email
asherfawwad@bide.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Basit, Director
Organizational Affiliation
Baqai Institute of Diabetology and Endocrinology (BIDE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baqai Institute of Diabetology and Endocrinology (BIDE)
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Basit, Professor
Phone
009221-36707179
Email
research@bide.edu.pk
First Name & Middle Initial & Last Name & Degree
Asher Fawwad, Professor
Phone
009221-36707179
Email
asherfawwad@bide.edu.pk
First Name & Middle Initial & Last Name & Degree
Abdul Basit, Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Vitamin D and Painful Diabetic Neuropathy
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