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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 22
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Hirabai Cowasji Jehangir Medical Research Institute
RECRUITING
Pune
Contact Information
Primary
Anuradha Khadilkar, MBBS MD DCH
anuradhavkhadilkar@gmail.com
+910206057004
Time Frame
Start Date: 2024-02-08
Estimated Completion Date: 2025-02-08
Participants
Target number of participants: 120
Treatments
Active_comparator: Arm 1: Only vitamin B12 supplements
Only vitamin B12 supplements 2.2 mcg OD for 24 weeks
Active_comparator: Arm 2: Vitamin B12 and oral iron supplements
Vitamin B12 2.2 mcg OD daily and oral iron 25 mg OD daily for 24 weeks
Active_comparator: Arm 3: Vitamin B12 and vitamin D3
Vitamin B12 2.2 mcg OD daily and vit D3 60,000 IU once in three months for 24 weeks
Related Therapeutic Areas
Sponsors
Leads: Hirabai Cowasji Jehangir Medical Research Institute

This content was sourced from clinicaltrials.gov

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