Actively Recruiting
Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
Led by Hirabai Cowasji Jehangir Medical Research Institute · Updated on 2024-06-05
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children, youth, or parents willing to participate with informed consent or assent
- Children or youth aged over 10 years
- Diabetes duration longer than 2 years
- Diagnosed with type 1 diabetes
You will not qualify if you...
- Age under 10 years
- Diabetes duration less than 2 years
- Currently receiving vitamin B12, vitamin D, or oral iron supplements
- Having any other disease affecting nerve or muscle function
- Not willing to consent to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, India, 411001
Actively Recruiting
Research Team
A
Anuradha Khadilkar, MBBS MD DCH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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