title: Annual high-dose vitamin D3 and mental well-being: randomised controlled trial.
abstract: BACKGROUND
  Epidemiological evidence supports a relationship between vitamin D and mental well-being, although evidence from large-scale placebo-controlled intervention trials is lacking.
  
  
  OBJECTIVE
  To examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms; and if there is an association between serum 25-hydroxyvitamin D levels and mental health.
  
  
  METHODS
  A double-blind, randomised, placebo-controlled trial of women aged 70 or older (the Vital D Study: ISRCTN83409867 and ACTR12605000658617). Participants were randomly assigned to receive 500 000 IU vitamin D(3) (cholecalciferol) orally or placebo every autumn/winter for 3-5 consecutive years. The tools utilised at various time points were the General Health Questionnaire, the 12-item Short Form Health Survey, the Patient Global Impression-Improvement scale and the WHO Well-Being Index. Serum 25-hydroxyvitamin D levels were measured in a subset of 102 participants.
  
  
  RESULTS
  In this non-clinical population, no significant differences between the vitamin D and placebo groups were detected in any of the measured outcomes of mental health. Serum 25-hydroxyvitamin D levels in the vitamin D group were 41% higher than the placebo group 12 months following their annual dose. Despite this difference, scores from the questionnaires did not differ. Furthermore, there was no interaction between those on antidepressant/anxiety medication at baseline and the treatment groups.
  
  
  CONCLUSIONS
  The lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D(3) is a practical intervention to prevent depressive symptoms in older community-dwelling women.
authors.affiliation: Department of Clinical and Biomedical Sciences, Barwon Health, PO Box 281, Geelong, Victoria, Australia 3220. kerrie@barwonhealth.org.au
authors.forename: Kerrie M
authors.initials: KM
authors.lastname: Sanders
authors.forename: Amanda L
authors.initials: AL
authors.lastname: Stuart
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Williamson
authors.forename: Felice N
authors.initials: FN
authors.lastname: Jacka
authors.forename: Seetal
authors.initials: S
authors.lastname: Dodd
authors.forename: Geoff
authors.initials: G
authors.lastname: Nicholson
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000188:drug therapy; D002762:Cholecalciferol / Q000008:administration & dosage / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D003863:Depression / Q000188:drug therapy / Q000453:epidemiology* / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control; D006304:Health Status; D006801:Humans; D057194:Intention to Treat Analysis; D008603:Mental Health / Q000706:statistics & numerical data*; D008875:Middle Aged; D010024:Osteoporosis / Q000517:prevention & control; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D010919:Placebos; D012307:Risk Factors; D013997:Time Factors; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood; D014808:Vitamin D Deficiency / Q000453:epidemiology; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D