Efficacy of Calcitriol in Recent Onset Type 1 Diabetes
IMDIABXIII
Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)
1 other identifier
interventional
N/A
1 country
5
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedMay 10, 2010
March 1, 2005
May 6, 2010
May 7, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
C peptide
evaluation of baseline and stimulated C peptide
Secondary Outcomes (1)
Glycometabolic control
Study Arms (2)
Calcitriol
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
- age at presentation between 11 and 35 years;
- duration of clinical disease (since the beginning of insulin therapy) \<12 weeks;
- baseline C-peptide \>0.25 nmol/l;
- no medical contra-indications or any other major chronic disease;
- willingness and capability to participate in a regular follow-up.
You may not qualify if:
- cardiovascular disease;
- renal disease;
- liver disease;
- neurological disorders;
- allergic diathesis;
- hyperparathyroidism;
- neoplasia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University Campus Bio Medico
Rome, 00128, Italy
Bambino Gesù Children's Hospital
Rome, Italy
Catholic University,
Rome, Italy
Sandro Pertini Hospital
Rome, Italy
University Sapienza
Rome, Italy
Related Publications (2)
Pitocco D, Crino 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. doi: 10.1111/j.1464-5491.2006.01921.x.
PMID: 16911633BACKGROUNDBizzarri C, Pitocco D, Napoli N, Di Stasio E, Maggi D, Manfrini S, Suraci C, Cavallo MG, Cappa M, Ghirlanda G, Pozzilli P; IMDIAB Group. No protective effect of calcitriol on beta-cell function in recent-onset type 1 diabetes: the IMDIAB XIII trial. Diabetes Care. 2010 Sep;33(9):1962-3. doi: 10.2337/dc10-0814.
PMID: 20805274DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2010
First Posted
May 10, 2010
Last Updated
May 10, 2010
Record last verified: 2005-03