Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Calcitriol

• Registration Number: NCT01120119
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement.

Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (\<12 weeks duration) and high basal C-peptide \>0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 \[1,25-(OH)2D3\] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-03
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-07
• Last Update Submitted: 2010-05-07
• Study First Posted: 2010-05-10
• Last Update Posted: 2010-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
2. age at presentation between 11 and 35 years;
3. duration of clinical disease (since the beginning of insulin therapy) <12 weeks;
4. baseline C-peptide >0.25 nmol/l;
5. no medical contra-indications or any other major chronic disease;
6. willingness and capability to participate in a regular follow-up.

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Exclusion Criteria

1. cardiovascular disease;
2. renal disease;
3. liver disease;
4. neurological disorders;
5. allergic diathesis;
6. hyperparathyroidism;
7. neoplasia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Calcitriol	Calcitriol	-
placebo	Calcitriol	-

Primary Outcome Measures

Name	Time	Method
C peptide		evaluation of baseline and stimulated C peptide

Secondary Outcome Measures

Name	Time	Method
Glycometabolic control		To measure insulin requirement and HbA1c

Trial Locations

Locations (5)

Bambino Gesù Children's Hospital; 🇮🇹 Rome, Italy

Sandro Pertini Hospital; 🇮🇹 Rome, Italy

University Sapienza; 🇮🇹 Rome, Italy

Catholic University,; 🇮🇹 Rome, Italy

University Campus Bio Medico; 🇮🇹 Rome, Italy