Vitamin D and Painful Diabetic Neuropathy | NCT05080530

Studies
Vitamin D and Painful Diabetic Neuropathy

NCT05080530

Sponsor

Baqai Institute of Diabetology and Endocrinology

Status

Unknown status

Last Update Posted

Jul 21, 2022Actual

Enrollment

216Estimated

Phase

Not Applicable

Conditions

Painful Diabetic Neuropathy

Interventions

Cholecalciferol

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2021Actual

Primary Completion Date

Aug 20, 2022Estimated

Completion Date

Aug 20, 2022Estimated

First Submitted Date

Sep 29, 2021

First Submission Date that Met QC Criteria

Oct 14, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2022

Last Update Posted Date

Jul 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdul Basit, Professor of Medicine, and Director, Baqai Institute of Diabetology and EndocrinologyPrincipal Investigator

Lead Sponsor

Baqai Institute of Diabetology and EndocrinologyOTHER

Collaborators

Name	Class
Scotmann Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

216Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. Normal Vit D (> 30ng/mL)	No Intervention	Follow-up after 3 months with standard treatment
2. Insufficient Vit D (20-30ng/mL)	Experimental	single oral dose capsule 200,000 IU of Cholecalciferol	Drug: Cholecalciferol
3. Insufficient Vit D (20-30ng/mL)	No Intervention	Follow-up after 3 months with standard treatment
4. Deficient Vit D	Experimental	single oral dose capsule 200,000 IU of Cholecalciferol	Drug: Cholecalciferol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug	Effect of Vitamin D on diabetic neuropathy symptoms	2. Insufficient Vit D (20-30ng/mL) 4. Deficient Vit D

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdul Basit, Professor	Contact	009221-36707179		research@bide.edu.pk
Asher Fawwad, Professor	Contact	009221-36707179		asherfawwad@bide.edu.pk

Overall Officials

Name	Affiliation	Role
Abdul Basit, Director	Baqai Institute of Diabetology and Endocrinology (BIDE)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baqai Institute of Diabetology and Endocrinology (BIDE)	Recruiting	Karachi	Sindh	74600	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided