Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
NCT ID: NCT06443593
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-02-08
2025-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm 1: Only vitamin B12 supplements
Only vitamin B12 supplements 2.2 mcg OD for 24 weeks
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
Arm 2: Vitamin B12 and oral iron supplements
Vitamin B12 2.2 mcg OD daily and oral iron 25 mg OD 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
Arm 3: Vitamin B12 and vitamin D3
Vitamin B12 2.2 mcg OD daily and vit D3 60,000 IU once in three months 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Children/ youth Age \> 10 years
3. Diabetes duration \> 2 years
4. Diagnosed with type 1 diabetes
Exclusion Criteria
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.
10 Years
22 Years
ALL
No
Sponsors
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Hirabai Cowasji Jehangir Medical Research Institute
OTHER
Responsible Party
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Dr. Anuradha Khadilkar
Consultant Pediatrician and Deputy Director
Locations
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Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JCDC/BHR/24/014
Identifier Type: -
Identifier Source: org_study_id
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