Trial ID: ISRCTN17354692
Other - Phase 2 - Recruiting
Background and study aims Many people have blood sugar levels above the normal range, but not high enough to be diagnosed as having diabetes. This is sometimes known as pre-diabetes. Celiac disease is a condition where the immune system attacks the body’s own tissues when gluten is eaten. Type 1 diabetes and celiac disease among with other autoimmune diseases may be prevented or regressed using the active hormone calcitriol or it's newer analogs. Calcitriol is the active form of vitamin D, normally made in the kidney. The aim of this study is to prove immunomodulating effects of timely administration of calcitriol and analogs for preventing, stopping progression, or succeeding in regression of prediabetes or subclinical Type-1 diabetes in children and adolescents. Who can participate? Patients aged six months to 18 years who have been identified as susceptible for type 1 diabetes or celiac disease. What does the study involve? Patients are assigned to oral calcitriol or paricalcitol at the highest individually tolerable doses and attend follow-up appointments every 3 - 6 months. What are the possible benefits and risks of participating? The main benefit will be to stop and revert seroconversion towards T1D-associated autoimmune targets, restore normal glucose metabolism and possibly acquire positive results regarding abs for celiac disease and hashimoto’s thyroiditis as well. The main risk is hypercalcemia-hypercalciuria and subsequent possible nephrocalcinosis. That is why all calcium metabolism parameters are carefully monitored with analogous titration of calcitriol/paricalcitol daily doses to prevent any adverse events. Where is the study run from? Pediatric Endocrine Clinics (Greece) When is the study starting and how long is it expected to run for? June 2010 to January 2030 Who is funding the study? Pediatric Endocrine Clinics (Greece) Who is the main contact? Dr Dimitrios T. Papadimitriou, dtpapadimitriou@pedoendo.gr
Pediatric Endocrine Clinics
Source: https://www.isrctn.com/