No Effect of the 1α,25-dihydroxyvitamin D3 on Beta Cell Residual Function and Insulin Requirement in Adults with New-Onset Type 1 Diabetes

  1. Anette-G. Ziegler, MD (anziegler{at}lrz.uni-muenchen.de)1
  1. 1 Diabetes Research Institute, Forschergruppe Diabetes e.V., Munich, Germany
  2. 2 DFG Center for Regenerative Therapies, Dresden, Germany

Abstract

Objective To determine whether the daily intake of 1α,25-dihydroxyvitamin D3 [1,25(OH)2D3] is safe and improves beta cell function in patients with recently diagnosed type 1 diabetes.

Research Design and Methods Safety was assessed in an open study of 25 patients aged 18 to 39 years with recent onset type 1 diabetes who received 0.25 μg 1,25(OH)2D3 daily for 9 months. An additional 40 patients were randomized to 0.25 μg 1,25(OH)2D3 or placebo daily for 9 months and followed for a total of 18 months for safety, beta cell function, insulin requirement, and glycemic control.

Results Safety assessment showed values in the normal range in nearly all patients, regardless if they received 1,25(OH)2D3 or placebo. No differences in AUC C-peptide, peak C-peptide, and fasting C-peptide after a mixed meal tolerance test between the treatment and placebo groups were observed at 9 months and 18 months after study entry, with approximately 40% loss for each parameter over the 18 month period. HbA1c and daily insulin requirement were similar between treatment and placebo groups throughout the study follow-up period.

Conclusions Treatment with 1,25(OH)2D3 at a daily dose of 0.25 μg was safe, but did not reduce loss of beta cell function.

Footnotes

    • Received December 16, 2009.
    • Accepted March 18, 2010.

This Article

  1. Diabetes Care
  1. All Versions of this Article:
    1. dc09-2297v1
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