title: Effect of moderate-dose vitamin D supplementation on insulin sensitivity in vitamin D-deficient non-Western immigrants in the Netherlands: a randomized placebo-controlled trial.
abstract: BACKGROUND
  Low serum 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with insulin resistance, the metabolic syndrome, and type 2 diabetes. Because many non-Western immigrants in the Netherlands are vitamin D deficient, obese, and at high risk of diabetes, vitamin D supplementation may contribute to prevent diabetes and insulin resistance.
  
  
  OBJECTIVE
  We examined the effect of vitamin D supplementation on insulin sensitivity and β cell function in overweight, vitamin D-deficient, non-Western immigrants at high risk of diabetes.
  
  
  METHODS
  The study was a 16-wk, randomized, placebo-controlled trial. A total of 130 non-Western immigrants with prediabetes (fasting glucose concentration >5.5 mmol/L or random glucose concentration from 7.8 to 11.1 mmol/L) and vitamin D deficiency (serum 25[OH]D concentration <50 nmol/L) were randomly assigned after stratification by sex to receive either cholecalciferol (1200 IU/d) or a placebo for 16 wk. All participants received 500 mg Ca/d as calcium carbonate. The primary outcome was the difference in the area under the curve of insulin and glucose after a 75-g oral-glucose-tolerance test after 4 mo of treatment. Secondary outcomes were insulin-sensitivity variables, β cell-function variables, and metabolic syndrome.
  
  
  RESULTS
  Mean serum 25(OH)D concentrations increased significantly in the vitamin D compared with placebo groups. After 4 mo of therapy, the mean between-group difference was 38 nmol/L (95% CI: 32.1, 43.9 nmol/L; P < 0.001). There was no significant effect on insulin sensitivity and β cell function. In a post hoc analysis, when patients with diabetes at baseline were excluded, a significant increase in the insulinogenic index was observed in participants who obtained a 25(OH)D concentration ≥60 nmol/L (P = 0.040).
  
  
  CONCLUSIONS
  Vitamin D supplementation in non-Western vitamin D-deficient immigrants with prediabetes did not improve insulin sensitivity or β cell function or change the incidence of metabolic syndrome. However, after the exclusion of diabetic subjects, an improvement in the insulinogenic index was observed in participants who obtained a 25(OH)D concentration ≥60 nmol/L. This trial was registered at trialregister.nl as NTR1827.
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Mirjam M
authors.initials: MM
authors.lastname: Oosterwerff
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Elisabeth Mw
authors.initials: EM
authors.lastname: Eekhoff
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Natasja M
authors.initials: NM
authors.lastname: Van Schoor
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: A Joan P
authors.initials: AJ
authors.lastname: Boeke
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Prabath
authors.initials: P
authors.lastname: Nanayakkara
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Rosa
authors.initials: R
authors.lastname: Meijnen
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Dirk L
authors.initials: DL
authors.lastname: Knol
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Mark Hh
authors.initials: MH
authors.lastname: Kramer
authors.affiliation: From the Department of Internal Medicine, Section of Endocrinology ZH4A65 (MMO, EMWE, PN, RM, MHHK, and PL), the EMGO Institute for Health and Care Research (NMVS), and the Department of Epidemiology and Biostatistics (DLK), VU University Medical Center, Amsterdam, Netherlands, and General Practice, Postjesweg, Amsterdam (AJPB).
authors.forename: Paul
authors.initials: P
authors.lastname: Lips
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002762:Cholecalciferol / Q000008:administration & dosage; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D054242:Emigrants and Immigrants; D005260:Female; D005500:Follow-Up Studies; D005951:Glucose Tolerance Test; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D050417:Insulin-Secreting Cells / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D009765:Obesity / Q000097:blood; D050177:Overweight / Q000097:blood; D011236:Prediabetic State / Q000097:blood / Q000517:prevention & control; D015995:Prevalence; D012307:Risk Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage*; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology*; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007328:Insulin; D014807:Vitamin D; D002762:Cholecalciferol