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

Hirabai Cowasji Jehangir Medical Research Institute

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: 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

Funder types: Other

Identifiers

NCT06443593

JCDC/BHR/24/014

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 10 to 22 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Arm 1: Only vitamin B12 supplements

Active Comparator group

Description:

Only vitamin B12 supplements 2.2 mcg OD for 24 weeks

Treatment:

Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg)

Arm 2: Vitamin B12 and oral iron supplements

Active Comparator group

Description:

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

Treatment:

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 group

Description:

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

Treatment:

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