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CompletedNCT01120119IMDIABXIIIUpdated May 10, 2010

Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

A Phase 2 interventional study of Calcitriol in Diabetes Mellitus, Type 1, sponsored by Campus Bio-Medico University. Completed at 5 sites in Italy. Open to participants aged 11 Years to 40 Years. Per ClinicalTrials.gov, last updated 2010-05-10.

Sponsored by Campus Bio-Medico University · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Ages
11 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

Browse Diabetes Mellitus studies →

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. cardiovascular disease;
  2. renal disease;
  3. liver disease;
  4. neurological disorders;
  5. allergic diathesis;
  6. hyperparathyroidism;
  7. neoplasia.
05

Study design

Phase
Phase 2

Study arms

  • Experimental
    Calcitriol

    Drug: Calcitriol

  • Placebo comparator
    placebo

    Drug: Calcitriol

Interventions

  • DrugCalcitriol
06

What researchers measure

Primary outcomes

  1. C peptide

    evaluation of baseline and stimulated C peptide

Secondary outcomes

  1. Glycometabolic control

    To measure insulin requirement and HbA1c

07

Study locations

5 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 16911633 ↗
  • 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. PubMed 20805274 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01120119
Lead sponsor
Campus Bio-Medico University
First posted
May 10, 2010
Last update
May 10, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.

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