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van CCT (UK)

van CCT (UK)

Diet and aggression

- candidate number21996
- NTR NumberNTR5176
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-apr-2015
- Secondary IDsNL51850.058.14 ZonMw dossier number 836031016
- Public TitleDiet and aggression
- Scientific TitleDiet and aggression: reducing aggression among chronic psychiatric inpatientsthrough supplementation of multivitamins, minerals and n-3 fatty acids
- hypothesismultivitamin-, mineral-, and n-3 fatty acids supplementation is effective in aggression reduction in chronic psychiatric inpatients.
- Healt Condition(s) or Problem(s) studiedChronic Psychiatric Problems, Aggression, Nutrition
- Inclusion criteriaage 18 or older
residing at a facility for long-term psychiatric care
- Exclusion criteriapregnancy
known contra indication for treatment with the supplements used in this study
expected discharge or transfer within the next eight weeks
current use of nutritional supplements and unwillingness to quit
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-jan-2016
- planned closingdate1-mrt-2018
- Target number of participants200
- InterventionsDuring the six-month intervention, one group will receive two daily supplements :
• Orthica Soft Multi, containing vitamins (B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene) and minerals (Calcium, Iodine, Copper, Magnesium, Selenium, Iron, Zinc, Potassium, Chrome, Manganese).
• Orthica Fish EPA MAX, containing n-3FA (EPA and DHA).
Both supplements are soft gel capsules and are available to the general public without prescription. Both supplements can be used as an addition to the existing diet. Patients can continue their normal dietary pattern and use of medication. The other group will receive two placebo capsules daily. Both supplements and placebos will be distributed through patients’ Baxters, which are filled by the local pharmacist.
- Primary outcomeThe main parameter in this study is the number of aggressive incidents in each arm, registered with the Staff Observation Aggression Scale- Revised Version (SOAS-R) (Nijman et al., 1999). As incidents may differ in severity and consequences, we make a distinction between minor (verbal aggression, threats, non-compliance with hospital rules, aggression towards objects, disinhibited [sexual] behaviour) and major (severe threats, fighting, assault on patients or staff, self-harm, suicide attempt) incidents. We carried out a pilot study to determine the prevalence of aggressive incidents among long-term psychiatric inpatients. This study yielded an estimate of 112 incidents per patient per year: 65 verbal aggression incidents, 12 incidents in which aggression was aimed at objects, 8 self-harm incidents, and 27 incidents in which physical aggression was aimed at others. We also monitored the time spent by nursing staff on each of these four types of incidents; verbal aggression took 80 minutes, aggression towards objects cost 77 minutes, self-harm cost 222 minutes, and physical aggression towards others cost 335 minutes per incidents. Based on these results, major incidents will be weighted by a factor 3.8.
- Secondary outcomeSecondary parameters are:
• patient barriers and facilitators in the acceptation of nutritional supplements, which will be identified in a short semi-structured interview.
• costs of time spent by staff members on aggression incidents and additional costs of incidents
• patient self-report aggression levels as measured with the Aangepaste Versie van de Agressie Vragenlijst (AVL-AV) (Hornsveld et al., 2009)
• patient observer rated aggression levels as measured with the Socil Dysfunction and Aggression Scale (SDAS) (Wistedt et al., 1990)
• patient observer rated affective symptoms as measured with the Verkorte Comprehensive Psychiatric Rating Scale (vCPRS) (Asberg et al., 1979)
• patient quality of life as measured with the World heath Organization Quality of Life (WHOQL-bref) (De Vries et al., 1995)
- TimepointsSOAS-r will be used continuaously throuhghout the trial to register aggressive incodents.
t0, baseline: blood sampling (to monitor compliance), AVL-AV, SDAS, vCPRS, WHOQL-bref
t1, 2 weeks: SDAS
t3, 2 months: AVL-AV, SDAS, vCPRS, WHOQL-bref
t4, 6 months: blood sampling (to monitor compliance), AVL-AV, SDAS, vCPRS, WHOQL-bref
- Trial web site
- statusplanned
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Leiden University Medical Center (LUMC), Atrium Innovations Inc.
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD21-apr-2015 - 30-jun-2015

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