title: A randomized placebo-controlled trial of alphacalcidol on the preservation of beta cell function in children with recent onset type 1 diabetes.
abstract: OBJECTIVE
  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 8-15, (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 μg 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=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.
  
  
  CONCLUSIONS
  The study confirmed that alfacalcidol can safely preserve beta cell function in newly diagnosed T1DM in children, with a stronger effect in males.
  
  
  BACKGROUND
  IRCT201205159753N1.
authors: Endocrinology and Metabolism Research Center (EMRC), Tehran University of Medical Sciences, Teheran, Iran; Faculty of Medicine and Health Sciences (FMHS), Universiti Putra Malaysia, 43400 Serdang, Selangor Darul Ehsan, Malaysia. Electronic address: asal_ataie2003@yahoo.com.
authors: Asal
authors: A
authors: Ataie-Jafari
authors: Seng-Cheong
authors: SC
authors: Loke
authors: Asmah B
authors: AB
authors: Rahmat
authors: Bagher
authors: B
authors: Larijani
authors: Farzaneh
authors: F
authors: Abbasi
authors: Melvin K S
authors: MK
authors: Leow
authors: Zaitun
authors: Z
authors: Yassin
mesh_terms: D000293:Adolescent; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D002096:C-Peptide / Q000097:blood; D002136:Calcium, Dietary / Q000008:administration & dosage / Q000097:blood; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006887:Hydroxycholecalciferols / Q000008:administration & dosage* / Q000097:blood; D006934:Hypercalcemia / Q000097:blood / Q000188:drug therapy; D007328:Insulin / Q000008:administration & dosage / Q000097:blood; D050417:Insulin-Secreting Cells / Q000187:drug effects* / Q000378:metabolism; D016014:Linear Models; D008297:Male; D015999:Multivariate Analysis; D016037:Single-Blind Method
chemical_list: D001786:Blood Glucose; D002096:C-Peptide; D002136:Calcium, Dietary; D006887:Hydroxycholecalciferols; D007328:Insulin; C008088:alfacalcidol
keywords: 1-alpha-hydroxycholecalciferol; Alfacalcidol; C-Peptide; DID; Diabetes mellitus; FCP; GLM-ANOVA; HLA; HbA1c; Hydroxycholecalciferols; Insulin-secreting cells; Iran; Randomized controlled trial; SMBG; T1DM; Type 1; VDR; daily insulin dosage per body weight; fasting C-peptide; glycated hemoglobin; human leukocyte antigen; multivariate general linear modeling repeated measures ANOVA; self-monitored blood glucose; type 1 diabetes; vitamin D receptor