title: Effect of cholecalciferol as adjunctive therapy with insulin on protective immunologic profile and decline of residual β-cell function in new-onset type 1 diabetes mellitus.
abstract: OBJECTIVE
  To evaluate the effect of vitamin D3 on cytokine levels, regulatory T cells, and residual β-cell function decline when cholecalciferol (vitamin D3 administered therapeutically) is given as adjunctive therapy with insulin in new-onset type 1 diabetes mellitus (T1DM).
  
  
  METHODS
  An 18-month (March 10, 2006, to October 28, 2010) randomized, double-blind, placebo-controlled trial was conducted at the Diabetes Center of São Paulo Federal University, São Paulo, Brazil.
  
  
  METHODS
  Thirty-eight patients with new-onset T1DM with fasting serum C-peptide levels greater than or equal to 0.6 ng/mL were randomly assigned to receive daily oral therapy of cholecalciferol, 2000 IU, or placebo.
  
  
  METHODS
  Levels of proinflammatory and anti-inflammatory cytokines, chemokines, regulatory T cells, hemoglobin A1c, and C-peptide; body mass index; and insulin daily dose.
  
  
  RESULTS
  Mean (SD) chemokine ligand 2 (monocyte chemoattractant protein 1) levels were significantly higher (184.6 [101.1] vs 121.4 [55.8] pg/mL) at 12 months, as well as the increase in regulatory T-cell percentage (4.55% [1.5%] vs 3.34% [1.8%]) with cholecalciferol vs placebo. The cumulative incidence of progression to undetectable (≤0.1 ng/mL) fasting C-peptide reached 18.7% in the cholecalciferol group and 62.5% in the placebo group; stimulated C-peptide reached 6.2% in the cholecalciferol group and 37.5% in the placebo group at 18 months. Body mass index, hemoglobin A1c level, and insulin requirements were similar between the 2 groups.
  
  
  CONCLUSIONS
  Cholecalciferol used as adjunctive therapy with insulin is safe and associated with a protective immunologic effect and slow decline of residual β-cell function in patients with new-onset T1DM. Cholecalciferol may be an interesting adjuvant in T1DM prevention trials.
authors: Diabetes Center of Endocrinology Division, Department ofMedicine, São Paulo Federal University, São Paulo, SP, Brazil. monicagabbay@gmail.com
authors: Mônica A L
authors: MA
authors: Gabbay
authors: Maria N
authors: MN
authors: Sato
authors: Claudia
authors: C
authors: Finazzo
authors: Alberto J S
authors: AJ
authors: Duarte
authors: Sergio A
authors: SA
authors: Dib
mesh_terms: D000293:Adolescent; D017668:Age of Onset; D001402:B-Lymphocytes / Q000187:drug effects / Q000502:physiology*; D015992:Body Mass Index; D001938:Brazil / Q000453:epidemiology; D002096:C-Peptide / Q000097:blood; D002648:Child; D002762:Cholecalciferol / Q000008:administration & dosage*; D016207:Cytokines / Q000097:blood; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007111:Immunity, Cellular / Q000187:drug effects* / Q000276:immunology; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D015995:Prevalence; D011446:Prospective Studies; D016896:Treatment Outcome; D014815:Vitamins / Q000008:administration & dosage
chemical_list: D002096:C-Peptide; D016207:Cytokines; D007004:Hypoglycemic Agents; D007328:Insulin; D014815:Vitamins; D002762:Cholecalciferol