Secondary prevention of type 1 diabetes in children and adolescents aged 6 months - 18 years using oral Vitamin D (calcitriol and analogues)

Secondary PREvention of type 1 diabetes with oral CALcitriol and analogues in children and adolescents aged 6 months - 18 yrs

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17354692

Enrollment

Registered

2020-05-05

Start date

2010-06-01

Completion date

Unknown

Last updated

2023-06-13

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

Conditions

Susceptibility for Type 1 Diabetes, Prediabetes Type 1, Newly diagnosed (subclinical) Type 1 Diabetes Nutritional, Metabolic, Endocrine

Interventions

In all children aged six months - 18 yrs either at high risk of T1D (at least 1 positive T1D associated autoantibody: IAA, ICA, anti-GAD, anti-IA2) or a predisposing HLA subtype (A, DQ, DR) or diagnos

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Already clinically treated T1D on intensified insulin protocols

Design outcomes

Primary

Measure	Time frame
Measured at follow up every 3 - 6 months from entry into the study until end of study: 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 2. Glucose metabolism (HbA1c, Fasting Glucose, Insulin and c-peptide levels) measured using urine test 3. OGTT response measured using oral glucose tolerance test	—

Measure

Time frame

Measured at follow up every 3 - 6 months from entry into the study until end of study: 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 2. Glucose metabolism (HbA1c, Fasting Glucose, Insulin and c-peptide levels) measured using urine test 3. OGTT response measured using oral glucose tolerance test

—

Secondary

Measure	Time frame
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	—

Countries

Cyprus, Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026