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.
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 inc...
| Publicado en: | Nutrition Journal Vol. 11; pp. 110 - 111 |
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| Autores principales: | , , , , , , , , , |
| Formato: | research randomized controlled trial Journal Article |
| Publicado: |
BioMed Central
2012
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104307657&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104307657 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14752891 1CYY jtl: Nutrition Journal issn: 14752891 maglogo: N pubinfo: dt: 2012 vid: 11 pid: 24147 pub: BioMed Central artinfo: ui: 104307657 NLM23241329 2011924093 10.1186/1475-2891-11-110 NLM23241329 PMC3545984 104307657 ppf: 110 ppct: 1 formats: fmt: @attributes: type: P tig: atl: 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. aug: au: Sarris, Jerome Cox, Katherine H M Camfield, David A Scholey, Andrew Stough, Con Fogg, Erin Kras, Marni White, David J Sali, Avni Pipingas, Andrew affil: Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia. kcox@swin.edu.au. sug: subj: Personal Satisfaction Vitamin B Complex Administration and Dosage Vitamins Administration and Dosage Adult Affect Drug Effects Double-Blind Studies Evaluation Research Female Human Male Middle Age Motor Activity Drug Effects New Zealand Questionnaires Sleep Drug Effects Stress, Physiological Drug Effects Vitamin B Complex Adverse Effects Vitamins Adverse Effects Young Adult Adult: 19-44 years Middle Aged: 45-64 years Female Male ab: 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.Conclusion: 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.Trial Registration: Prior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au) ACTRN12611000092998. pubtype: Academic Journal doctype: research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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