title: Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial.
abstract: BACKGROUND
  While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported.
  
  
  METHODS
  Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16), three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers) was employed to ensure methodological rigour. Participant's experiences were categorised as "positive" or "negative" and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender). Usual experiences were categorised and discussed separately.
  
  
  RESULTS
  Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022) and enhanced mood (p=.027). The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin group having minor digestive complaints.
  
  
  CONCLUSIONS
  This represents the first documented qualitative investigation of participants' experience of chronic administration of a multivitamin. Results uncovered a range of subjective beneficial effects that are consistent with quantitative data from previously published randomised controlled trials examining the effects of multivitamins and B vitamin complexes on mood and well-being.
  
  
  BACKGROUND
  Prior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au) ACTRN12611000092998.
authors.affiliation: Department of Psychiatry, The University of Melbourne, Melbourne, Australia.
authors.forename: Jerome
authors.initials: J
authors.lastname: Sarris
authors.forename: Katherine H M
authors.initials: KH
authors.lastname: Cox
authors.forename: David A
authors.initials: DA
authors.lastname: Camfield
authors.forename: Andrew
authors.initials: A
authors.lastname: Scholey
authors.forename: Con
authors.initials: C
authors.lastname: Stough
authors.forename: Erin
authors.initials: E
authors.lastname: Fogg
authors.forename: Marni
authors.initials: M
authors.lastname: Kras
authors.forename: David J
authors.initials: DJ
authors.lastname: White
authors.forename: Avni
authors.initials: A
authors.lastname: Sali
authors.forename: Andrew
authors.initials: A
authors.lastname: Pipingas
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects; D009520:New Zealand; D010549:Personal Satisfaction; D012890:Sleep / Q000187:drug effects; D013312:Stress, Physiological / Q000187:drug effects; D011795:Surveys and Questionnaires; D014803:Vitamin B Complex / Q000008:administration & dosage* / Q000009:adverse effects; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D014815:Vitamins; D014803:Vitamin B Complex