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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Dietary supplement: Tablet VitaBliss vitamin B12 (2.2 mcg); Dietary supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg); Dietary supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anuradha Khadilkar, MBBS MD DCH; Phone Number: +910206057004; Email: anuradhavkhadilkar@gmail.com

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Recruiting
      • Hirabai Cowasji Jehangir Medical Research Institute
      • Contact: Anuradha V. Khadilkar, MBBS,MD,DCH; Phone Number: +910206057004; Email: anuradhavkhadilkar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children/ parents/ youth willing to participate in the study with an informed consent/ assent.
2. Children/ youth Age > 10 years
3. Diabetes duration > 2 years
4. Diagnosed with type 1 diabetes

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Only vitamin B12 supplements; Only vitamin B12 supplements 2.2 mcg OD for 24 weeks	Dietary supplement: Tablet VitaBliss vitamin B12 (2.2 mcg); Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily 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	Dietary supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg); 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
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	Dietary supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic muscle function	Maximum relative power (watt/kg) will be assessed using jumping mechanography	6 months
Dynamic muscle function	Maximum relative force (Newton/kg) will be assessed using jumping mechanography	6 months
Glycemic control (HbA1c)	Glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays	6 months

Collaborators and Investigators

• Sponsor: Hirabai Cowasji Jehangir Medical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): February 8, 2025
• Study Completion (Estimated): February 8, 2025

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: vitamin D; Diabetic neuropathy; vitamin B12; oral iron; Nerve conduction velocity; children and youth with type 1 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Micronutrients; Hematinics; Vitamins; Vitamin B 12; Hydroxocobalamin; Vitamin B Complex
• Other Study ID Numbers: JCDC/BHR/24/014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No