Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— IMDIABXIII  

Official title:

Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120119
• Other study ID #: CLF-1 2005-000751-15
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2010
• Last updated: May 7, 2010

Study information

• Verified date: March 2005
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 40 Years

Eligibility

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.

Exclusion Criteria:

1. cardiovascular disease;

2. renal disease;

3. liver disease;

4. neurological disorders;

5. allergic diathesis;

6. hyperparathyroidism;

7. neoplasia.

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Drug:
• Calcitriol

Locations

Country	Name	City	State
Italy	Bambino Gesù Children's Hospital	Rome
Italy	Catholic University,	Rome
Italy	Sandro Pertini Hospital	Rome
Italy	University Campus Bio Medico	Rome
Italy	University Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Pitocco D, Crinò A, Di Stasio E, Manfrini S, Guglielmi C, Spera S, Anguissola GB, Visalli N, Suraci C, Matteoli MC, Patera IP, Cavallo MG, Bizzarri C, Pozzilli P; IMDIAB Group. The effects of calcitriol and nicotinamide on residual pancreatic beta-cell function in patients with recent-onset Type 1 diabetes (IMDIAB XI). Diabet Med. 2006 Aug;23(8):920-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C peptide	evaluation of baseline and stimulated C peptide
Secondary	Glycometabolic control	To measure insulin requirement and HbA1c