Clinical trial NCT05080530: Vitamin D and Painful Diabetic Neuropathy
Official title: Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Painful Diabetic Neuropathy
Lead sponsor: Baqai Institute of Diabetology and Endocrinology
Sponsor class: OTHER
Collaborators: name: Scotmann Pharmaceuticals
First posted: 2021-10-15
Enrollment: 216
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from baseline in DN4 score.
timeFrame: 3 months
measure: Change from baseline in serum HbA1c.
timeFrame: 3 months
measure: Change from baseline in serum vitamin D.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Baqai Institute of Diabetology and Endocrinology (BIDE)
state: Sindh
Study officials:
affiliation: Baqai Institute of Diabetology and Endocrinology (BIDE)
name: Abdul Basit, Director
role: PRINCIPAL_INVESTIGATOR
References: