Background & 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.
Methods: Subjects from outpatient clinic were randomized to intervention and control groups. Inclusion:
(1) age 8e15, (2) T1DM, (3) duration <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 mg 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.
Results: Of 61 subjects, 7 dropped out. GLM-ANOVA showed that groups were different (p ¼ 0.019, Etasquared ¼ 0.087), with no significant covariates. FCP was higher and DID lower in the intervention group,
with males having stronger responses to alfacalcidol (p ¼ 0.001). No adverse effects were observed.
Conclusions: The study confirmed that alfacalcidol can safely preserve beta cell function in newly diagnosed T1DM in children, with a stronger effect in males