Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT06443593
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-02-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve conduction velocity', 'timeFrame': '6 months', 'description': 'Change in nerve conduction velocity of children and adolescents with type 1 diabetes after supplementation with vitamin B12, oral iron and vitamin D'}, {'measure': 'Serum vitamin B12, serum ferritin, serum vitamin D3', 'timeFrame': '6 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Dynamic muscle function', 'timeFrame': '6 months', 'description': 'Maximum relative power (watt/kg) will be assessed using jumping mechanography'}, {'measure': 'Dynamic muscle function', 'timeFrame': '6 months', 'description': 'Maximum relative force (Newton/kg) will be assessed using jumping mechanography'}, {'measure': 'Glycemic control (HbA1c)', 'timeFrame': '6 months', 'description': 'Glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic neuropathy', 'children and youth with type 1 diabetes', 'vitamin B12', 'vitamin D', 'oral iron', 'Nerve conduction velocity'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children/ parents/ youth willing to participate in the study with an informed consent/ assent.\n2. Children/ youth Age \\> 10 years\n3. Diabetes duration \\> 2 years\n4. Diagnosed with type 1 diabetes\n\nExclusion Criteria:\n\n1. Age \\< 10 years\n2. Diabetes duration \\< 2 years\n3. Children/ youth receiving vitamin B12, vitamin D and/or oral iron supplements\n4. Children/ youth with any other disease condition involving nerve or muscle function\n5. Children/ parents/ youth not willing to consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06443593', 'acronym': 'NCVRCT', 'briefTitle': 'Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT', 'organization': {'class': 'OTHER', 'fullName': 'Hirabai Cowasji Jehangir Medical Research Institute'}, 'officialTitle': 'Vitamin B12, Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'JCDC/BHR/24/014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Only vitamin B12 supplements', 'description': 'Only vitamin B12 supplements 2.2 mcg OD for 24 weeks', 'interventionNames': ['Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Vitamin B12 and oral iron supplements', 'description': 'Vitamin B12 2.2 mcg OD daily and oral iron 25 mg OD daily for 24 weeks', 'interventionNames': ['Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3: Vitamin B12 and vitamin D3', 'description': 'Vitamin B12 2.2 mcg OD daily and vit D3 60,000 IU once in three months for 24 weeks', 'interventionNames': ['Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)']}], 'interventions': [{'name': 'Tablet VitaBliss vitamin B12 (2.2 mcg)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral vitamin B12 supplement 2.2 mcg from BLISS WELNESS, Bliss Lifesciences, LLP to be administered once daily for 24 weeks', 'armGroupLabels': ['Arm 1: Only vitamin B12 supplements']}, {'name': 'Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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', 'armGroupLabels': ['Arm 2: Vitamin B12 and oral iron supplements']}, {'name': 'Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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', 'armGroupLabels': ['Arm 3: Vitamin B12 and vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Anuradha V. Khadilkar, MBBS,MD,DCH', 'role': 'CONTACT', 'email': 'anuradhavkhadilkar@gmail.com', 'phone': '+910206057004'}], 'facility': 'Hirabai Cowasji Jehangir Medical Research Institute', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'centralContacts': [{'name': 'Anuradha Khadilkar, MBBS MD DCH', 'role': 'CONTACT', 'email': 'anuradhavkhadilkar@gmail.com', 'phone': '+910206057004'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hirabai Cowasji Jehangir Medical Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Pediatrician and Deputy Director', 'investigatorFullName': 'Dr. Anuradha Khadilkar', 'investigatorAffiliation': 'Hirabai Cowasji Jehangir Medical Research Institute'}}}}