An interventional study of Cholecalciferol in Painful Diabetic Neuropathy, sponsored by Baqai Institute of Diabetology and Endocrinology. Status unknown at 1 site in Pakistan. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Baqai Institute of Diabetology and Endocrinology · Not applicable, Interventional, and Treatment
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.
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.
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:
617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.
This study's planned enrollment of 216 is above the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Baqai Institute of Diabetology and Endocrinology is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Follow-up after 3 months with standard treatment
single oral dose capsule 200,000 IU of Cholecalciferol
Drug: Cholecalciferol
Follow-up after 3 months with standard treatment
single oral dose capsule 200,000 IU of Cholecalciferol
Drug: Cholecalciferol
Effect of Vitamin D on diabetic neuropathy symptoms
Also known as: Sunny D™ (Vitamin D3) Softgel Capsule
Change from baseline in DN4 score.
The change will be observed with the help of neuropathic pain assessment questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Baqai Institute of Diabetology and Endocrinology