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临床试验/NCT06443593
NCT06443593招募中不适用

Vitamin B12, Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes

Hirabai Cowasji Jehangir Medical Research Institute2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Nerve conduction velocity

研究概览

简要总结

Type 1 diabetes can complicate to peripheral neuropathy due to preferential involvement of small unmyelinated nerve fibers (pain and temperature sensation) followed by myelinated nerve fibers (vibration and proprioception). The SEARCH for diabetes in youth study found diabetic neuropathy in 7% of T1D youth. The clinical form of peripheral neuropathy is rare in childhood and pathophysiological changes begin during childhood and accelerate in puberty. Adolescents with these changes can be picked up more reliably by electrophysiological studies than by clinical examination. Nerve conduction studies are the gold standard diagnostic tests for detection of peripheral neuropathy. Role of vitamin B12 in nerve regeneration is well known while causal association of vitamin D deficiency in type 1 diabetes and its role in axonal degeneration is also reported. The previous ongoing studies from authors' group have shown relationship between poor oral iron intake and subclinical neuropathy in children with type 1 diabetes (manuscript in submission). The present randomised clinical trial is aimed at assessing vitamin B12, vitamin D and iron supplementation for improvement of nerve conduction velocities in children and youth with type 1 diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children/ parents/ youth willing to participate in the study with an informed consent/ assent.
  • Children/ youth Age > 10 years
  • Diabetes duration > 2 years
  • Diagnosed with type 1 diabetes

排除标准

  • Age < 10 years
  • Diabetes duration < 2 years
  • Children/ youth receiving vitamin B12, vitamin D and/or oral iron supplements
  • Children/ youth with any other disease condition involving nerve or muscle function
  • Children/ parents/ youth not willing to consent to participate in the study.

结局指标

主要结局

Nerve conduction velocity

时间窗: 6 months

Change in nerve conduction velocity of children and adolescents with type 1 diabetes after supplementation with vitamin B12, oral iron and vitamin D

Serum vitamin B12, serum ferritin, serum vitamin D3

时间窗: 6 months

Change in serum vitamin B12, serum ferritin, serum vitamin D3 levels using standardized assays in children and adolescents with type 1 diabetes after supplementation with vitamin B12, oral iron and vitamin D

次要结局

  • Glycemic control (HbA1c)(6 months)
  • Dynamic muscle function(6 months)

研究者

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

Dr. Anuradha Khadilkar

Consultant Pediatrician and Deputy Director

Hirabai Cowasji Jehangir Medical Research Institute

研究点 (2)

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