A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes

作者：Ataie Jafari Asal; Loke Seng Cheong^*; Rahmat Asmah B; Larijani Bagher; Abbasi Farzaneh; Leow Melvin K S; Yassin Zaitun

来源：Clinical Nutrition, 2013, 32(6): 911-917.

DOI：10.1016/j.clnu.2013.01.012

• C-Peptide
• Diabetes mellitus
• Type 1
• Hydroxycholecalciferols
• Insulin-secreting cells
• Iran
• Randomized controlled trial

Background %26 aims: This participant-blinded parallel-group randomized placebo-controlled study demonstrated that alfacalcidol (vitamin D analogue) preserves beta cell function in newly diagnosed type 1 diabetes (T1DM) in children. %26lt;br%26gt;Methods: Subjects from outpatient clinic were randomized to intervention and control groups. Inclusion: (1) age 8-15, (2) T1DM, (3) duration %26lt;8 weeks, (4) no chronic diseases, (5) stable diet. Exclusion: (1) vitamin D, calcium supplements or fortified foods, (2) hypercalcemia. Intervention group received alfacalcidol 0.25 mu g twice daily, while control group received placebo. Insulin given physician-titrated to blood glucose. Safety monitored by serum calcium and phosphate. Beta cell function assessed at 0, 3, 6 months using fasting C-peptide (FCP) and daily insulin dosage per body weight (DID). Primary outcome measured using multivariate repeated measures GLM-ANOVA, with FCP and DID as primary measures and age, gender, sunlight exposure, 25-hydroxy vitamin D, and HbA1c as covariates. %26lt;br%26gt;Results: Of 61 subjects, 7 dropped out. GLM-ANOVA showed that groups were different (p = 0.019, Eta-squared = 0.087), with no significant covariates. FCP was higher and DID lower in the intervention group, with males having stronger responses to alfacalcidol (p = 0.001). No adverse effects were observed. %26lt;br%26gt;Conclusions: The study confirmed that alfacalcidol can safely preserve beta cell function in newly diagnosed T1DM in children, with a stronger effect in males. %26lt;br%26gt;Clinical Trial Reg.

• 出版日期2013-12