Micronutrient supplementation for nerve health in children with type 1 diabetes
Vitamin B12, Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes
NA · Hirabai Cowasji Jehangir Medical Research Institute · NCT06443593
This study is testing if giving vitamin B12, vitamin D, and iron supplements can help improve nerve health in children and teens with type 1 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 10 Years to 22 Years |
| Sex | All |
| Sponsor | Hirabai Cowasji Jehangir Medical Research Institute (other) |
| Locations | 1 site (Pune, Maharashtra) |
| Trial ID | NCT06443593 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of micronutrient supplementation, specifically vitamin B12, vitamin D, and oral iron, on nerve conduction velocity in children and youth diagnosed with type 1 diabetes. It aims to assess whether these supplements can improve nerve function and potentially prevent or mitigate diabetic neuropathy, which is a common complication in this population. Participants will undergo nerve conduction studies to evaluate the efficacy of the interventions. The study targets children and youth over the age of 10 with a diabetes duration of more than two years.
Who should consider this trial
Good fit: Ideal candidates for this study are children and youth aged over 10 years who have been diagnosed with type 1 diabetes for more than two years.
Not a fit: Patients under the age of 10 or those with a diabetes duration of less than two years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nerve health and reduced incidence of diabetic neuropathy in children with type 1 diabetes.
How similar studies have performed: Previous studies have indicated a relationship between micronutrient deficiencies and neuropathy, suggesting that this approach may hold promise, although it is not extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children/ parents/ youth willing to participate in the study with an informed consent/ assent. 2. Children/ youth Age \> 10 years 3. Diabetes duration \> 2 years 4. Diagnosed with type 1 diabetes Exclusion Criteria: 1. Age \< 10 years 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.
Where this trial is running
Pune, Maharashtra
- Hirabai Cowasji Jehangir Medical Research Institute — Pune, Maharashtra, India (RECRUITING)
Study contacts
- Study coordinator: Anuradha Khadilkar, MBBS MD DCH
- Email: anuradhavkhadilkar@gmail.com
- Phone: +910206057004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Diabetic neuropathy, children and youth with type 1 diabetes, vitamin B12, vitamin D, oral iron, Nerve conduction velocity