Reducing Aggression Among People With an Intellectual Disability

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Aggressive Behaviour Among People With an Intellectual Disability Through Supplementation of Vitamins, Minerals and n-3 Fatty Acids

Conditions
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Aggression, Intellectual Disability

Intervention / Treatment
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* Dietary Supplement: Multivitamin, mineral & n-3 FA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multivitamin, mineral & n-3 FA<br>The daily supplementation of multivitamin- and mineral in 2 capsules and n-3 fatty acids in 2 softgel capsules. | Dietary Supplement: Multivitamin, mineral & n-3 FA<br>* 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<br>|
| Placebo Comparator: Placebo<br>The placebo consists of daily supplementation of 2 capsules with rice bran extract, hypromellose and 1.6 mg riboflavin. And 2 softgel capsules with a vegetable oil. | Dietary Supplement: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggression | The amount of aggressive behavior registered with the Modified Overt Aggression Scale (MOAS).This is a four item aggression scale which distinguishes verbal aggression, aggression to objects, self-aggression and physical aggression to others. | The aggression will be reported daily by the staff during a period of 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggression and anti-social behavior | Aggressive- and anti-social behavior measured with the SDAS-11. An eleven item aggression scale. The severity of each item can range from 1 to 5 on a Likert scale. | At baseline and in the 18th week | 
| Quality of Life IDQOL-16 | Quality of life measured with the IDQOL-16. | At baseline and in the 18th week | 
| Cortisol status | The cortisol status measured with hair analyses. | At baseline and in the 18th week | 
| Microbiome | The micobiome measured with feces analysis. | At baseline and in the 18th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aggression, aggressive behavior, nutritional supplements, dietary supplements, vitamin, mineral, omega-3, n-3 fatty acids, intellectual disability