Reducing Aggression Among People With an Intellectual Disability
Condition: Aggression; Intellectual Disability
MeSH terms: Intellectual Disability; Aggression
Study type: Interventional

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.
    

Intervention name(s): Multivitamin, mineral & n-3 FA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The 2 multi vitamin capsules with the two multi vitamin softgel capsules will be handed out once a day during a meal by the staff of the care organization. The compliance will be registered; The placebo of the multi vitamin capsules and the two multi vitamin softgel capsules will be handed out once a day during a meal by the staff of the care organization. The compliance will be registered
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aggression; aggressive behavior; nutritional supplements; dietary supplements; vitamin, mineral; omega-3; n-3 fatty acids; intellectual disability