Painful Diabetic Neuropathy Clinical Trial
Official title:
Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
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.
Status | Recruiting |
Enrollment | 216 |
Est. completion date | August 20, 2022 |
Est. primary completion date | August 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Baqai Institute of Diabetology and Endocrinology (BIDE) | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Baqai Institute of Diabetology and Endocrinology | Scotmann Pharmaceuticals |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in DN4 score. | The change will be observed with the help of neuropathic pain assessment questionnaire. | 3 months | |
Primary | 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 | |
Primary | 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 |
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