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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Only vitamin B12 supplements | Active Comparator | Only vitamin B12 supplements 2.2 mcg OD for 24 weeks |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anuradha Khadilkar, MBBS MD DCH | Contact | +910206057004 | anuradhavkhadilkar@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirabai Cowasji Jehangir Medical Research Institute | Recruiting | Pune | Maharashtra | 411001 | India |
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| 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 |
|
| 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 |
|
| 6 months |
| Glycemic control (HbA1c) | Glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays | 6 months |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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