Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change from baseline in DN4 score.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
2. Insufficient Vit D (20-30ng/mL)
single oral dose capsule 200,000 IU of Cholecalciferol
干预措施: Cholecalciferol (Drug)
4. Deficient Vit D
single oral dose capsule 200,000 IU of Cholecalciferol
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Change from baseline in DN4 score.
时间窗: 3 months
The change will be observed with the help of neuropathic pain assessment questionnaire.
Change from baseline in serum HbA1c.
时间窗: 3 months
The change will be observed in the serum values of glycated hemoglobin at the end point after the administration of vitamin D.
Change from baseline in serum vitamin D.
时间窗: 3 months
The cholecalciferol (Vitamin D) level in serum will be observed at the end point after the administration of vitamin D.
次要结局
未报告次要终点
研究者
Abdul Basit
Professor of Medicine, and Director
Baqai Institute of Diabetology and Endocrinology