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

Type 1 Diabetes Clinical Trial

— NCVRCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443593
• Other study ID #: JCDC/BHR/24/014
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: February 8, 2025

Study information

• Verified date: May 2024
• Source: Hirabai Cowasji Jehangir Medical Research Institute
• Contact: Anuradha Khadilkar, MBBS MD DCH
• Phone: +910206057004
• Email: anuradhavkhadilkar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 8, 2025
• Est. primary completion date: February 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
India	Hirabai Cowasji Jehangir Medical Research Institute	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Hirabai Cowasji Jehangir Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

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