Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443593
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-16
Brief Title:
Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
Sponsor:
Hirabai Cowasji Jehangir Medical Research Institute
Organization:
Hirabai Cowasji Jehangir Medical Research Institute
Study Overview
Official Title:
Vitamin B12 Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NCVRCT
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None