Reducing Aggressive Behaviour Among People With an Intellectual Disability Through Supplementation of Vitamins, Minerals and n-3 Fatty Acids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 10
- 主要终点
- Aggression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo with the appearance as the dietary supplements
入排标准
- 年龄范围
- 12 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Aggression
时间窗: The aggression will be reported daily by the staff during a period of 18 weeks
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.
次要结局
- Quality of Life IDQOL-16(At baseline and in the 18th week)
- Cortisol status(At baseline and in the 18th week)
- Aggression and anti-social behavior(At baseline and in the 18th week)
- Microbiome(At baseline and in the 18th week)
研究者
Erik J. Giltay, MD, PhD
MD, PhD
Leiden University Medical Center