Clinical trial NCT03212092: Reducing Aggression Among People With an Intellectual Disability
Official title: Reducing Aggressive Behaviour Among People With an Intellectual Disability Through Supplementation of Vitamins, Minerals and n-3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggression
Intellectual Disability
Keywords: Aggression
aggressive behavior
nutritional supplements
dietary supplements
vitamin, mineral
omega-3
n-3 fatty acids
intellectual disability
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 137
Sex: ALL
Minimum age (years): 12
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a pragmatic multicenter randomized double-blind placebo-controlled intervention trial with an intervention period of 4 months. Since the washout period of several components of dietary supplements is unknown we chose a parallel design.
Primary purpose: TREATMENT

Brief summary: The study is an randomised controlled trial (RCT) to test whether supplementation of vitamins, minerals and n-3 fatty acids may reduce aggressive behavior in people with intellectual disabilities.

Detailed description: Rationale: The prevalence of aggression among people with an intellectual disability is high. Previous studies have demonstrated the potential of multivitamin-, mineral-, and n-3 fatty acids (n-3FA) supplementation to reduce antisocial behavior and aggression among schoolchildren and prisoners.

Objective: To test the hypothesis that multivitamin-, mineral-, and n-3 FA supplementation reduces aggression among adolescents and young adults with an intellectual disability.

Study design: Pragmatic, randomised, double blind, placebo controlled, multicentre intervention study.

Study population: People with an intellectual disability aged between 12-39 years, living at a care or treatment facility or having day care, who have shown aggressive behaviour.

Intervention: During 16 weeks, people in the active condition receive 4 supplements daily: 2 Bonusan Multi Vital Forte Actief (Multi vitamin and mineral) and 2 Bonusan Omega-3 Forte (n-3 fatty acids) while people in the placebo condition receive 4 placebo capsules.

Main study parameters/endpoints: The main study parameter is the number of aggressive incidents from baseline to endpoint (16 weeks post baseline), as measured using the Dutch version of the Modified Overt Aggression Scale (MOAS).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Clients who wish to participate enter a 2-week run-in phase during which they take 4 placebo capsules daily. After positive evaluation of this phase clients are randomised to either the active or control condition. Participants will then start the daily use of 4 supplement capsules or 4 placebo capsules, which continues for 16 weeks. At baseline and endpoint 2 questionnaires will be administered: the Intellectual Disability Quality of Life (IDQOL-16) and the Dutch Healthy Diet Food Frequency Questionnaire (DHD-FFQ). Small hair and faeces samples will be collected at baseline and 16 weeks. The data collection will take less than an hour per client and will take place at the location where the client resides. Aggression incidents will be registered by staff members using the MOAS. Also a staff member will fill in the Social Dysfunction Aggression Scale (SDAS) at baseline and endpoint, measuring observed levels of aggression and social dysfunction. The risks of participating in this study are minimal. The use of the Bonusan Multi Vital Forte Actief, or similar supplements has not been associated with any significant health risks and side effects. Potential benefits of participating in this study is an increase in quality of life through improved nutritional status, as well as a reduction of aggressive incidents. As this is a pragmatic trial in which the main objective is to determine whether the use of supplements has the potential to reduce the number of aggressive incidents among adolescents and young adults with an intellectual disability, it is imperative to include these subjects.

Eligibility criteria: Inclusion Criteria:

* intellectual disability
* living or day care in a health care organization
* age 12 till 39 years
* has a at least once a week an aggressive incident.

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* people with Williams syndrome, hyperparathyroid or hemochromatosis.
* Current use of nutritional supplements and refusal to quit this use for the duration of the study.
* Failure to complete the two-week run-in phase.
* The use of the following medication: levothyroxine, methyldopa en levodopa

Primary outcomes:
measure: Aggression
timeFrame: The aggression will be reported daily by the staff during a period of 18 weeks
Secondary outcomes:
measure: Aggression and anti-social behavior
timeFrame: At baseline and in the 18th week
measure: Quality of Life IDQOL-16
timeFrame: At baseline and in the 18th week
measure: Cortisol status
timeFrame: At baseline and in the 18th week
measure: Microbiome
timeFrame: At baseline and in the 18th week
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Trajectum
state: Overijssel
city: Gouda
country: Netherlands
facility: Gemiva-SVG
state: Zuid Holland
city: Leidschendam
country: Netherlands
facility: Schakenbosch
state: Zuid Holland
city: Amersfoort
country: Netherlands
facility: s Heeren Loo
city: Baarn
country: Netherlands
facility: Amerpoort
city: Gorinchem
country: Netherlands
facility: Syndion
city: Tilburg
country: Netherlands
facility: Amarant
Study officials:
affiliation: Leiden University Medical Center
name: Erik Giltay, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Long SJ, Benton D. A double-blind trial of the effect of docosahexaenoic acid and vitamin and mineral supplementation on aggression, impulsivity, and stress. Hum Psychopharmacol. 2013 May;28(3):238-47. doi: 10.1002/hup.2313. Epub 2013 Apr 29.
citation: Raine A, Cheney RA, Ho R, Portnoy J, Liu J, Soyfer L, Hibbeln J, Richmond TS. Nutritional supplementation to reduce child aggression: a randomized, stratified, single-blind, factorial trial. J Child Psychol Psychiatry. 2016 Sep;57(9):1038-46. doi: 10.1111/jcpp.12565. Epub 2016 May 11.
citation: Tammam JD, Steinsaltz D, Bester DW, Semb-Andenaes T, Stein JF. A randomised double-blind placebo-controlled trial investigating the behavioural effects of vitamin, mineral and n-3 fatty acid supplementation in typically developing adolescent schoolchildren. Br J Nutr. 2016 Jan 28;115(2):361-73. doi: 10.1017/S0007114515004390. Epub 2015 Nov 17.
citation: Gajos JM, Beaver KM. The effect of omega-3 fatty acids on aggression: A meta-analysis. Neurosci Biobehav Rev. 2016 Oct;69:147-58. doi: 10.1016/j.neubiorev.2016.07.017. Epub 2016 Jul 20.
citation: 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.