Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT

Last updated: May 29, 2024
Sponsor: Hirabai Cowasji Jehangir Medical Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Tablet VitaBliss vitamin B12 (2.2 mcg)

Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)

Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg)

Clinical Study ID

NCT06443593
JCDC/BHR/24/014
  • Ages 10-22
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Children/ parents/ youth willing to participate in the study with an informedconsent/ assent.

  2. Children/ youth Age > 10 years

  3. Diabetes duration > 2 years

  4. Diagnosed with type 1 diabetes

Exclusion

Exclusion Criteria:

  1. Age < 10 years

  2. Diabetes duration < 2 years

  3. Children/ youth receiving vitamin B12, vitamin D and/or oral iron supplements

  4. Children/ youth with any other disease condition involving nerve or muscle function

  5. Children/ parents/ youth not willing to consent to participate in the study.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Tablet VitaBliss vitamin B12 (2.2 mcg)
Phase:
Study Start date:
February 08, 2024
Estimated Completion Date:
February 08, 2025

Connect with a study center

  • Hirabai Cowasji Jehangir Medical Research Institute

    Pune, Maharashtra 411001
    India

    Active - Recruiting

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