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

NCT06443593 | Recruiting

• 1 other identifier: JCDC/BHR/24/014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Diabetic neuropathy; children and youth with type 1 diabetes; vitamin B12; vitamin D; oral iron; Nerve conduction velocity

Outcome Measures

Primary Outcomes (2)

• Nerve conduction velocity

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

  6 months

• Serum vitamin B12, serum ferritin, serum vitamin D3

  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

  6 months

Secondary Outcomes (3)

• Dynamic muscle function

  6 months

• Dynamic muscle function

  6 months

• Glycemic control (HbA1c)

  6 months

Study Arms (3)

Arm 1: Only vitamin B12 supplements

ACTIVE COMPARATOR

Only vitamin B12 supplements 2.2 mcg OD for 24 weeks

Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg)

Arm 2: Vitamin B12 and oral iron supplements

ACTIVE COMPARATOR

Vitamin B12 2.2 mcg OD daily and oral iron 25 mg OD daily for 24 weeks

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

Arm 3: Vitamin B12 and vitamin D3

ACTIVE COMPARATOR

Vitamin B12 2.2 mcg OD daily and vit D3 60,000 IU once in three months for 24 weeks

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

Interventions

Tablet VitaBliss vitamin B12 (2.2 mcg) DIETARY_SUPPLEMENT

Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily for 24 weeks

Arm 1: Only vitamin B12 supplements

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

Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily for 24 weeks and oral iron 25 mg from Emcure Pharmaceuticals Ltd. to be administered once daily for 24 weeks

Arm 2: Vitamin B12 and oral iron supplements

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

Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily for 24 weeks and oral vitamin D3 (60000 IU) from Eris Lifesciences Ltd to be administered once in 3 months for 24 weeks

Arm 3: Vitamin B12 and vitamin D3

Eligibility Criteria

• Age: 10 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hirabai Cowasji Jehangir Medical Research Institute: lead

Study Sites (1)

Hirabai Cowasji Jehangir Medical Research Institute

Pune, Maharashtra, 411001, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Central Study Contacts

Anuradha Khadilkar, MBBS MD DCH

CONTACT

+910206057004; anuradhavkhadilkar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatrician and Deputy Director

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 5, 2024
• Study Start: February 8, 2024
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: June 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)