No Effect of the 1α, 25-Dihydroxyvitamin D3 n β-Cell Residual Function and Insulin Requirement in Adults With New-Onset Type 1 Diabetes.

OBJECTIVE-- To determine whether daily intake of 1α,25-dihydroxyvitamin D[sub 3] [1,25(OH)[sub 2]D[sub 3]] is safe and improves β-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 18-39 years with recent-onset type 1 diabetes who received 0.25 µg 1,25(OH)[sub 2]D[sub 3] daily for 9 months. An additional 40 patients were randomly assigned to 0.25 µg 1,25(OH)[sub 2]D[sub 3] or placebo daily for 9 months and followed for a total of 18 months for safety, I3-cell function, insulin requirement, and glycemic control. RESULTS-- Safety assessment showed values in the normal range in nearly all patients, regardless of whether they received 1,25(OH)[sub 2]D[sub 3] 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 and 18 months after study entry, with ∼40% loss for each parameter over the 18-month period. A 1C and daily insulin requirement were similar between treatment and placebo groups throughout the study follow-up period. CONCLUSIONS -- Treatment with 1,25(OH)[sub 2]D[sub 3] at a daily dose of 0.25 µg was safe but did not reduce loss of β-cell function. [ABSTRACT FROM AUTHOR]