Type 1 DiabetesNCVRCTNCT06443593
Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
A study testing Tablet VitaBliss vitamin B12 (2.2 mcg), Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg) and Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU) in people with Type 1 Diabetes, run by Hirabai Cowasji Jehangir Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 22 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Tablet VitaBliss vitamin B12 (2.2 mcg), Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg) and Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 8 Feb 2024to 8 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, 411001
Anuradha V. Khadilkar, MBBS,MD,DCH, +910206057004, anuradhavkhadilkar@gmail.com
About this study
Official title: Vitamin B12, Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Tablet VitaBliss vitamin B12 (2.2 mcg), Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg), Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU)
- Keywords
- Diabetic neuropathy, children and youth with type 1 diabetes, vitamin B12, vitamin D, oral iron, Nerve conduction velocity
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Only vitamin B12 supplements | Active comparator | Only vitamin B12 supplements 2.2 mcg OD for 24 weeks Receives: Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) |
| 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 Receives: 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 | Vitamin B12 2.2 mcg OD daily and vit D3 60,000 IU once in three months for 24 weeks Receives: Dietary Supplement: Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (3)
Dynamic muscle function
Maximum relative power (watt/kg) will be assessed using jumping mechanography
Measured: 6 months
Dynamic muscle function
Maximum relative force (Newton/kg) will be assessed using jumping mechanography
Measured: 6 months
Glycemic control (HbA1c)
Glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start8 Feb 2024
- Primary completion8 Feb 2025 (estimated)
- Study completion8 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hirabai Cowasji Jehangir Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anuradha Khadilkar, Hirabai Cowasji Jehangir Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443593
- Sponsor's protocol ID
- JCDC/BHR/24/014
- Acronym
- NCVRCT
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B12, Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06443593
- Acronym / sponsor ID
- NCVRCT / JCDC/BHR/24/014
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetic neuropathy, children and youth with type 1 diabetes, vitamin B12, vitamin D, oral iron, Nerve conduction velocity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hirabai Cowasji Jehangir Medical Research InstituteUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 8 Feb 2025 (estimated)
- Study completion
- 8 Feb 2025 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Only vitamin B12 supplements | Active comparator | Dietary Supplement: 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 | Active comparator | Dietary Supplement: 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 | Active comparator | Dietary Supplement: 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 |
Who may qualify
- Ages
- 10 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Arm 1: Only vitamin B12 supplements |
| 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 | Dietary supplement | Arm 2: Vitamin B12 and oral iron supplements |
| 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 | Dietary supplement | Arm 3: Vitamin B12 and vitamin D3 |
Primary outcome
Nerve conduction velocity
Time frame: 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
Time frame: 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
3 secondary outcomes
Dynamic muscle function
Time frame: 6 months
Dynamic muscle function
Time frame: 6 months
Glycemic control (HbA1c)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet VitaBliss vitamin B12 (2.2 mcg), Tablet VitaBliss vitamin B12 (2.2 mcg) and Syrup Orofer (5 ml = 50 mg) and Tablet VitaBliss vitamin B12 (2.2 mcg) and Tablet Tayo (60000 IU) in people with Type 1 Diabetes, run by Hirabai Cowasji Jehangir Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anuradha Khadilkar, MBBS MD DCH (+910206057004, anuradhavkhadilkar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction velocity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.