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Efficacy of Calcitriol in Recent Onset Type 1 Diabetes (IMDIABXIII)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Calcitriol
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Diabetes Mellitus, Type 1

Eligibility Criteria

11 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Campus Bio Medico
  • Bambino Gesù Children's Hospital
  • Catholic University,
  • Sandro Pertini Hospital
  • University Sapienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcitriol

placebo

Arm Description

Outcomes

Primary Outcome Measures

C peptide
evaluation of baseline and stimulated C peptide

Secondary Outcome Measures

Glycometabolic control
To measure insulin requirement and HbA1c

Full Information

First Posted
May 6, 2010
Last Updated
May 7, 2010
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT01120119
Brief Title
Efficacy of Calcitriol in Recent Onset Type 1 Diabetes
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Study Phase
Phase 2

8. Arms, Groups, and Interventions

Arm Title
Calcitriol
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Primary Outcome Measure Information:
Title
C peptide
Description
evaluation of baseline and stimulated C peptide
Secondary Outcome Measure Information:
Title
Glycometabolic control
Description
To measure insulin requirement and HbA1c

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: cardiovascular disease; renal disease; liver disease; neurological disorders; allergic diathesis; hyperparathyroidism; neoplasia.
Facility Information:
Facility Name
University Campus Bio Medico
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Bambino Gesù Children's Hospital
City
Rome
Country
Italy
Facility Name
Catholic University,
City
Rome
Country
Italy
Facility Name
Sandro Pertini Hospital
City
Rome
Country
Italy
Facility Name
University Sapienza
City
Rome
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16911633
Citation
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.
Results Reference
background
PubMed Identifier
20805274
Citation
Bizzarri 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.
Results Reference
derived

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Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

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