Secondary prevention of type 1 diabetes in children and adolescents aged 6 months - 18 years using oral Vitamin D (calcitriol and analogues)
Phase 2
- Conditions
- Susceptibility for Type 1 Diabetes, Prediabetes Type 1, Newly diagnosed (subclinical) Type 1 DiabetesNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN17354692
- Lead Sponsor
- Pediatric Endocrine Clinics
- Brief Summary
2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23302101 (added 30/03/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37238410/ (added 30/05/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Age six months - 18 years
2. Positive HLA subtypes for T1D susceptibility
3. At least one positive T1D associated autoantibody
4. Positive HLA or autoantibodies for celiac disease
Exclusion Criteria
Already clinically treated T1D on intensified insulin protocols
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measured at follow up every 3 - 6 months from entry into the study until end of study:<br>1. Type 1 Diabetes associated autoantibodies [Serum levels of islet cell autoantibodies (ICA), autoantibodies to glutamic acid decarboxylase (Gad 65) antigen (anti-GAD65), anti-insulin autoantibodies (IAA), and autoantibodies against protein tyrosine phosphatase IA2 (anti-IA2)] measured using ELISA kits<br>2. Glucose metabolism (HbA1c, Fasting Glucose, Insulin and c-peptide levels) measured using urine test<br>3. OGTT response measured using oral glucose tolerance test
- Secondary Outcome Measures
Name Time Method Title and prevention or regression of celiac disease autoantibodies, thyroid autoantibodies and other autoimmune diseases if known and applicable measured using ELISA kits at follow up every 3 - 6 months from entry into the study until end of study