Vitamin D for the Treatment of Painful Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 主要终点
- Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the DN4 Neuropathic Pain Diagnostic Questionnaire
研究概览
简要总结
The main objective of the study is to assess the effect of vitamin D treatment on painful diabetic neuropathy in Pakistan.
This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single dose of 600,000 IU of Vitamin D.
All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to participate in the study. The change in painful diabetic neuropathy scores was assessed using DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at each visit.
详细描述
Background Painful diabetic neuropathy (DPN) is common in patients with long-standing diabetes mellitus. The prevalence of neuropathy approaches 50% in those with diabetes for 25 years. Among patients with neuropathy, 11.6% with type 1 diabetes and 32.1% with type 2 diabetes have neuropathic pain. In our recent observational study of a large cohort of diabetic patients from primary care in northwest England (n = 15,692), painful diabetic neuropathy (PDN), assessed using the neuropathy symptom score (NSS) and neuropathy disability score (NDS) (NSS >/=5 and NDS >/=3) was 21%, and the prevalence of painful symptoms (NSS >/=5) was 34%. Despite less neuropathy in South Asians (14%) compared to Europeans (22%) (P < 0.0001), painful symptoms were greater in South Asians (38 vs. 32%, P < 0.0001) and they maintained a 50% increased risk of painful neuropathy symptoms (P < 0.0001).
The potential for an association between vitamin D and a beneficial effect on neuropathy is based on experimental data which has shown that vitamin D3 can upregulate NGF and the products of its neuronal target genes resulting in an improvement in experimental diabetic neuropathy. Vitamin D insufficiency has recently been associated with retinopathy and self-reported peripheral neuropathy symptoms even after adjusting for demographic factors, obesity, comorbidities, use of medications for neuropathy and diabetes duration and glycemic control. Of course, there may be some overlap between the symptoms associated with vitamin D deficiency and diabetic neuropathy, which may partly explain the excess painful symptoms we have observed in Asians, particularly as the latter have excess vitamin D deficiency.
The preliminary data suggests there is an urgent need to undertake a blinded placebo-controlled randomised trial of vitamin D3 in the treatment of diabetic peripheral neuropathy.
Aims:
- To see the association of Serum Vitamin D3 levels in type 2 diabetic subjects with Painful neuropathy
- Effect of intervention through injectable Vitamin D3 on Painful diabetic neuropathy Study Design The study is a single centre, single (patient)-blinded, evaluation of injectable cholecalciferol in the treatment of painful diabetic neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with type 1 or type 2 diabetes aged 18 to 80 years
- •Patient has a diagnosis of painful diabetic neuropathy and reports symmetrical painful symptoms in distal extremities for a period of 1-5 years prior to the study, and symptoms were attributable to DPN
- •HbA1c level ≤ 11% at the screening visit were considered eligible to participate in the study.
排除标准
- •Patients with renal impairment or hypo or hyperthyroidism,
- •Patients currently taking vitamin D supplementation or anti - epileptic or anti - tuberculosis medication,
- •Patients with a previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, HIV infection and peripheral neuropathy due to a non-diabetic cause
- •Pregnant or breast feeding female patients
- •Patients allergic to nuts or any nut products and patients participating in any other interventional research trial were excluded from the study.
研究组 & 干预措施
vitamin D
single IM dose 600,000 IU of cholecalciferol
干预措施: cholecalciferol (Drug)
结局指标
主要结局
Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the DN4 Neuropathic Pain Diagnostic Questionnaire
时间窗: 5 months
DN4 Neuropathic Pain Diagnostic Questionnaire contains six questions which reflect positive symptoms for pain i.e. question 1, 2, 3, 4, 5 and 10 (sensations of burning, painful cold, electric shocks, tingling, pins \& needles and brushing).
次要结局
- Improvement in painful diabetic neuropathy by the use of vitamin D Injections (600,000 IU) assessed with the SF-Mac Gill Pain Questionnaire.(5 months)
研究者
Abdul Basit
Professor of Medicine, Director of Baqai Institute of Diabetology and Endocrinology
Baqai Institute of Diabetology and Endocrinology