Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation
NCT ID: NCT02498106
Last Updated: 2019-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2015-05-31
2019-10-31
Brief Summary
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Detailed Description
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The main study parameter is the number of aggressive incidents from baseline (t0) to endpoint (six months post baseline, t3). Patients who wish to participate enter a 2-week run-in phase in which they take 2 placebo capsules daily. After positive evaluation of this run-in phase patients are randomized to the active or the control condition. Participants will then start the daily use of 2 supplement capsules or 2 placebo capsules, which will continue for 6 months. At 3 time points (at baseline \[t0\] and at 2 and 6 months post-baseline \[t2 and t3\]), three questionnaires measuring feelings of aggression, quality of life, and psychiatric symptoms will be administered. Also, at t0 and t3 (micro)nutrient status will be determined. Finally, at 4 time points (t0, 2 weeks post baseline \[t1\], t2 and t3), nursing staff will report on observed levels of aggression and social dysfunction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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nutritional supplement
2 Orthica Soft Multi Mini capsules and 1 Orthica Fish EPA Mini capsule per day; duration: 6 months
Orthica Soft Multi Mini and Orthica Fish EPA Mini
daily intake of 2 Orthica Soft Multi Mini capsules (containing vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene\] and minerals \[Iodine, Copper, Selenium, Iron, Zinc, Chrome, Manganese\]) and 1 Orthica Fish EPA Mini capsule (containing n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\])
placebo
During 6 months one group receives 3 placebo supplements daily with identical look and feel to Orthica Soft Multi Mini and Orthica Fish EPA Mini
Orthica Soft Multi Mini and Orthica Fish EPA Mini
daily intake of 2 Orthica Soft Multi Mini capsules (containing vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene\] and minerals \[Iodine, Copper, Selenium, Iron, Zinc, Chrome, Manganese\]) and 1 Orthica Fish EPA Mini capsule (containing n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\])
Interventions
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Orthica Soft Multi Mini and Orthica Fish EPA Mini
daily intake of 2 Orthica Soft Multi Mini capsules (containing vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene\] and minerals \[Iodine, Copper, Selenium, Iron, Zinc, Chrome, Manganese\]) and 1 Orthica Fish EPA Mini capsule (containing n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\])
Eligibility Criteria
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Inclusion Criteria
* age 18 or over
Exclusion Criteria
* breastfeeding
* known contra-indication for using the supplements used in this study
* expected discharge or transfer within the next 8 weeks
* current use of dietary supplements and refusal to stop using these for the duration of the study
* failure to complete run-in phase
* contra-indication for the use of pork-gelatin
18 Years
ALL
No
Sponsors
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Atrium Innovations
INDUSTRY
Leiden University Medical Center
OTHER
Responsible Party
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Erik J. Giltay, MD, PhD
Erik J. Giltay, MD, PhD
Principal Investigators
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Erik J. Giltay, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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GGZ Centraal
Ermelo, Gelderland, Netherlands
GGZ Eindhoven
Eindhoven, Noord-Braband, Netherlands
GGZ Delfland
Delft, South Holland, Netherlands
Fivoor
Den Dolder, Utrecht, Netherlands
Rivierduinen
Oegstgeest, , Netherlands
Parnassia
The Hague, , Netherlands
Countries
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References
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Hornsveld RH, Muris P, Kraaimaat FW, Meesters C. Psychometric properties of the aggression questionnaire in Dutch violent forensic psychiatric patients and secondary vocational students. Assessment. 2009 Jun;16(2):181-92. doi: 10.1177/1073191108325894. Epub 2008 Oct 13.
Nijman H, Palmstierna T. Measuring aggression with the staff observation aggression scale--revised. Acta Psychiatr Scand Suppl. 2002;(412):101-2. doi: 10.1034/j.1600-0447.106.s412.21.x.
Asberg M, Schalling D. Construction of a new psychiatric rating instrument, the Comprehensive Psychopathological Rating Scale (CPRS). Prog Neuropsychopharmacol. 1979;3(4):405-12. doi: 10.1016/0364-7722(79)90055-9.
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
Schoenthaler SJ, Bier ID. The effect of vitamin-mineral supplementation on juvenile delinquency among American schoolchildren: a randomized, double-blind placebo-controlled trial. J Altern Complement Med. 2000 Feb;6(1):7-17. doi: 10.1089/acm.2000.6.7.
Gesch CB, Hammond SM, Hampson SE, Eves A, Crowder MJ. Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Randomised, placebo-controlled trial. Br J Psychiatry. 2002 Jul;181:22-8. doi: 10.1192/bjp.181.1.22.
Zaalberg A, Nijman H, Bulten E, Stroosma L, van der Staak C. Effects of nutritional supplements on aggression, rule-breaking, and psychopathology among young adult prisoners. Aggress Behav. 2010 Mar-Apr;36(2):117-26. doi: 10.1002/ab.20335.
Legare N, Brosseau E, Joyal CC. Omega-3 and violence in schizophrenia. Schizophr Res. 2007 Nov;96(1-3):269. doi: 10.1016/j.schres.2007.05.023. Epub 2007 Jul 16. No abstract available.
Benton D. The impact of diet on anti-social, violent and criminal behaviour. Neurosci Biobehav Rev. 2007;31(5):752-74. doi: 10.1016/j.neubiorev.2007.02.002. Epub 2007 Mar 4.
de Bles NJ, Gast DAA, van der Slot AJC, Didden R, van Hemert AM, Rius-Ottenheim N, Giltay EJ. Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour. J Eval Clin Pract. 2022 Aug;28(4):607-614. doi: 10.1111/jep.13653. Epub 2022 Jan 17.
Other Identifiers
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836031016
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL51850.058.14
Identifier Type: REGISTRY
Identifier Source: secondary_id
5176
Identifier Type: REGISTRY
Identifier Source: secondary_id
P14.332
Identifier Type: -
Identifier Source: org_study_id
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