FindTrial
Sign In

A Trial to See the Effect of Three Drugs Vitamin D, Verapamil, and Lansoprazole on Cells That Secrete Insulin in Patients With Newly Diagnosed Type 1 Diabetes

Effect of vitamin D, verapamil, and lansoprazole on residual beta-cell function in children with newly diagnosed type 1 diabetes:-an open label randomised controlled pilot trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084335
Enrollment
60
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E10- Type 1 diabetes mellitus

Interventions

Intervention1: vitamin D, verapamil and lansoprazole along with standard treatment: along with standard treatment-Vitamin D - 60,000 units orally every 2 weeks for 6 months, Lansoprazole weight-bas

Sponsors

Mohit Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with T1D (type 1 diabetes) between 7-18 years. 2. Newly diagnosed T1D (in the last 30 days, based on ISPAD criteria for diabetes and one of the three pancreatic autoantibody positivity) 3. Baseline stimulated C-peptide level of greater than 0.5 ng/mL

Exclusion criteria

Exclusion criteria: 1. Those children who were already started on vitamin D or lansoprazole or verapamil for a different indication 2. Those who had a history of any serious adverse effects/acute drug reaction after initiation of vitamin D, verapamil or lansoprazole in the past 3. Patients on medications that can cause drug interactions with vitamin D, verapamil, or lansoprazole 4. Past history of any congenital/acquired heart disease/heart blocks. 5. Any active infections 6. White blood cell counts less than 3000 leukocytes per microlitre, Platelets below 1,00,000/mm3, absolute neutrophil count below 1500 per mm3 7. Liver dysfunction (jaundice, elevated AST or ALT for more than a week at the time of enrolment) 8. Renal dysfunction (serum creatinine greater than 1 mg/dL) 9. T1D-associated illnesses such as celiac disease, thyroid disorder, etc

Design outcomes

Primary

MeasureTime frame
To determine the mean difference in stimulated C-peptide from baseline to endpoint (at 6 months) in children with new-onset T1D on combination therapy- vitamin D, verapamil, and lansoprazole versus standard treatmentTimepoint: 6 months—

Secondary

MeasureTime frame
1. Change in HbA1c from baseline to endpoint 2. Changes in averaged fasting blood glucose and mean blood glucose from baseline to endpoint 3. Change in daily insulin requirements 4. Change in serum gastrin levels 5. Partial remission duration and frequency in cases and controlsTimepoint: 6 months—

Countries

India

Contacts

Public ContactDevi dayal

PGIMER, Chandigarh

drdevidayal@gmail.com9872072472

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026