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临床试验/NCT07644520
NCT07644520尚未招募2 期

Effect of Vitamin D Supplementation on Neuropathic Pain, Sleep Quality, and Quality of Life in Patients With Diabetic Peripheral Neuropathy

Tanta University0 个研究点目标入组 150 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
150

研究概览

简要总结

Introduction Diabetic peripheral neuropathy (DPN) is among the most common chronic complications of diabetes mellitus and represents a major cause of morbidity, impaired quality of life, sleep disturbance, chronic pain, and functional disability.(Kurz et al., 2026) The pathogenesis of DPN is multifactorial and involves oxidative stress, chronic inflammation, endothelial dysfunction, mitochondrial injury, and microvascular ischemia, leading to progressive nerve damage.(Yang et al., 2025) Despite the availability of symptomatic therapies such as gabapentin, pregabalin, and duloxetine, many patients continue to experience persistent neuropathic symptoms, poor sleep quality, and impaired daily functioning. Existing pharmacological therapies are often associated with incomplete response, adverse effects, and high economic burden.(Kaye et al., 2025) Recently, vitamin D has attracted attention beyond its classical role in calcium and bone metabolism. Experimental and clinical evidence suggest that vitamin D possesses neuroprotective, anti-inflammatory, immunomodulatory, and antioxidative properties. Vitamin D receptors are widely distributed in neuronal tissues, Schwann cells, and immune cells, suggesting a potential role in nerve repair and modulation of neuropathic pain pathways.(Liu et al., 2025) Several observational studies have demonstrated a high prevalence of vitamin D deficiency among patients with diabetic neuropathy, and low serum vitamin D levels have been associated with increased neuropathic pain severity and poorer quality of life. However, available interventional studies remain limited and have produced inconsistent findings regarding the therapeutic benefit of vitamin D supplementation in DPN.(Ou et al., 2021) Therefore, this study aims to evaluate whether vitamin D supplementation can improve neuropathic pain, sleep quality, and health-related quality of life among patients with diabetic peripheral neuropathy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must fulfill all the following:
  • 1. Age between 18 and 75 years
  • Diagnosed with type 2 diabetes mellitus according to ADA criteria
  • Clinically diagnosed diabetic peripheral neuropathy
  • Neuropathic symptoms for at least 3 months
  • Vitamin D insufficiency or deficiency:
  • Serum 25(OH)D < 30 ng/mL
  • Stable antidiabetic treatment for at least 3 months

排除标准

  • Type 1 diabetes mellitus
  • Current vitamin D supplementation within the previous 3 months
  • Severe renal impairment (eGFR < 30 mL/min/1.73m²)
  • Severe hepatic impairment
  • Hypercalcemia
  • Malabsorption syndromes
  • Pregnancy or lactation
  • Peripheral neuropathy due to causes other than diabetes:
  • Vitamin B12 deficiency
  • Hypothyroidism
  • Alcoholic neuropathy
  • Chemotherapy-induced neuropathy
  • Active malignancy
  • Severe psychiatric illness

研究组 & 干预措施

test

Active Comparator

干预措施: Vitamin D (Dietary Supplement)

control

No Intervention

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khadija Ahmed Mhrose Glal

Director

Tanta University

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