The objective of this study is to test whether supplementation of vitamins, minerals and n-3 fatty acids may reduce aggressive behavior in people with intellectual disabilities. The research is relevant for the practice of social work. Theā¦
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the amount of aggressive behavior registered
with the Modified Overt Aggression Scale (MOAS).
Secondary outcome
The secondary study parameters are:
Aggressive- and anti-social behavior measured by the SDAS.
Quality of life measured by IDQOL-16
The cortisol status measured by hair analyses.
The micobiome measured with the aid of a feces analysis.
Background summary
Aggressive behaviour by intellectual disabled people is relatively common, with
an estimated prevalence of in between 9% and 24%. The prevalence in
institutionalized care recipients is even higher, reaching up to 45%.
Aggressive behavior has consequences for both care recipients, as for the care
workers. It contributes to stress and can lead to injury and illness. This
becomes evident in a survey conducted by CNV on 112 social workers in care
institutions for intellectual disabled people. More than 29% of the employees
do not feel safe at work, 59% of the employees had to undergo a medical
treatment because of an aggression incident and 88% of the social workers had
to deal with physical aggression by clients (CNV, 2015). Aggressive behavior is
more than physical aggression only. It is defined as: "any verbal, non-verbal
or physical behavior that is threatening or is causing actual physical damage
(to the client themselves, others or property)" (Morrison, 1990).
Study objective
The objective of this study is to test whether supplementation of vitamins,
minerals and n-3 fatty acids may reduce aggressive behavior in people with
intellectual disabilities. The research is relevant for the practice of social
work. The intervention with nutritional supplements can be combined with
behavior-regulating medication or counseling methods to reduce aggressive
behavior. Because of it's safety, the intervention is appropriate to apply to
people with intellectual disabilities. An additional advantage is its low cost.
Study design
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.
Intervention
The intervention consists of a daily supplementation of 2 multivitamin and
mineral capsules "Multi Vital Forte" by Bonusan, supplemented with n-3 fatty
acids "Omega 3 forte" in softgel capsules by Bonusan. The supplements or
placebo's are provided 1x daily by the social care worker on location.
Study burden and risks
After completion of the informed consent procedure and a run in period of two
weeks, the participant will spend two times an hour with the researcher for the
completion of 2 questionnaires. The first time is at intake and it starts with
a list of background information of the client, followed by a DHD-FFQ and a
IDQOL-16. In addition a fecal sample is taken. In the last week the DHD-FFQ and
IDQOL-16 are taken again and hair sample is also taken in addition to the stool
sample. If the client is unable to complete the questionnaire in a meaningful
way a social worker of the client is asked as a proxy.
For 16 weeks the participant will take one multi-vitamin mineral tablet and 2
softgel capsules with Omega 3 fatty acids daily. The use of the supplements
'0737 MVF' and the 'Omega-3 forte' from Bonusan has not been associated with
any significant risks.
The aggression will be recorded by the social worker using a MOAS form.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
intellectually disabled (IQ<80)
Residing, or day care at a social welfare organization.
Age 12 till 39
At least once a week aggressive behaviour.
Exclusion criteria
Pregnancy
Breastfeeding
People with: Williams syndrom, Wilson's desease, primary hyperparathyroidism
and hemochromatosis.
Current use of multi vitamins, -minerals and omega-3 fatty acids
supplementation and refusal to quit this at least two moths before the
beginning of the intervention
Allergy for fish
The use of the following medication: levothyroxine, methyldopa en levodopa
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT03212092 |
CCMO | NL60839.058.17 |