Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
- Conditions
- Type 1 Diabetes
- Interventions
- 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)
- Registration Number
- NCT06443593
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Only vitamin B12 supplements Tablet VitaBliss vitamin B12 (2.2 mcg) Only vitamin B12 supplements 2.2 mcg OD for 24 weeks Arm 2: Vitamin B12 and oral iron supplements Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg) Vitamin B12 2.2 mcg OD daily and oral iron 25 mg OD daily for 24 weeks Arm 3: Vitamin B12 and vitamin D3 Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU) Vitamin B12 2.2 mcg OD daily and vit D3 60,000 IU once in three months for 24 weeks
- Primary Outcome Measures
Name Time Method Nerve conduction velocity 6 months Change in nerve conduction velocity of children and adolescents with type 1 diabetes after supplementation with vitamin B12, oral iron and vitamin D
Serum vitamin B12, serum ferritin, serum vitamin D3 6 months 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
- Secondary Outcome Measures
Name Time Method Glycemic control (HbA1c) 6 months Glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays
Dynamic muscle function 6 months Maximum relative force (Newton/kg) will be assessed using jumping mechanography
Trial Locations
- Locations (1)
Hirabai Cowasji Jehangir Medical Research Institute
🇮🇳Pune, Maharashtra, India