Vitamin D and Painful Diabetic Neuropathy

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baqai Institute of Diabetology and Endocrinology
• Treatments: Cholecalciferol; Vitamin D

Criteria

Inclusion Criteria:

• Insulin dependent diabetes

• Insulin independent diabetes

• Age range between 25 to 80 years

• Glycated hemoglobin (HbA1c) level must be ≤11%

• 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