Dataset Information

Dietary supplements for aggressive behaviour in people with intellectual disabilities: A randomised controlled crossover trial.

ABSTRACT:

Background

Aggressive incidents are common in people with intellectual disabilities. Therefore, we aimed to assess whether supplementation of multivitamins, minerals, and omega-3 fatty acids (FA) reduces aggressive incidents.

Methods

We conducted a randomised, triple blind, placebo controlled, single crossover intervention trial. People with intellectual disabilities or borderline intellectual functioning, between 12 and 40 years of age, and showing aggressive behaviour were included. Participants received either a daily dose of dietary supplements, or placebo. Primary outcome was the number of aggressive incidents, measured using the Modified Overt Aggression Scale (MOAS).

Results

there were 113 participants (placebo, n = 56), of whom 24 (placebo, n = 10) participated in the crossover phase of the trial. All 137 trajectories were included in the analyses. There was no significant difference in mean number of aggressive incidents per day between those assigned to supplements and those who received placebo (rate ratio = 0.93: 95% Confidence Interval [CI] = 0.59-1.45).

Conclusion

In this pragmatic trial, we did not find significant differences in the outcomes between the supplement and placebo arms. The COVID-19 pandemic started midway through our trial, this may have affected the results.

SUBMITTER: Gast DAA

PROVIDER: S-EPMC10092216 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Dietary supplements for aggressive behaviour in people with intellectual disabilities: A randomised controlled crossover trial.

Gast David A A DAA Didden Robert R Westera Johanna J JJ van de Rest Ondine O van Hemert Albert M AM Giltay Erik J EJ

Journal of applied research in intellectual disabilities : JARID 20221012 1

<h4>Background</h4>Aggressive incidents are common in people with intellectual disabilities. Therefore, we aimed to assess whether supplementation of multivitamins, minerals, and omega-3 fatty acids (FA) reduces aggressive incidents.<h4>Methods</h4>We conducted a randomised, triple blind, placebo controlled, single crossover intervention trial. People with intellectual disabilities or borderline intellectual functioning, between 12 and 40 years of age, and showing aggressive behaviour were inclu ...[more]

PMID: 36224110

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Project description:BackgroundCOVID-19 has caused morbidity, hospitalisation and mortality worldwide. Despite effective vaccines, there is still a need for effective treatments, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. We sought to evaluate whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc could improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.MethodsParticipants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.Results90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.InterpretationIn this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.Trial registration numberNCT04780061.

Project description:BackgroundThe effects of dietary intervention in managing sarcopenic obesity are controversial, and behavior change techniques are lacking in previous studies which are important for the success of dietary intervention. This study aimed to evaluate the feasibility and preliminary effects of a dietary behaviour change (DBC) intervention on managing sarcopenic obesity among community-dwelling older people in the community.MethodsA two-armed, RCT was conducted. Sixty community-dwelling older adults (≥ 60 years old) with sarcopenic obesity were randomised into either the experimental group (n = 30), receiving a 15-week dietary intervention combined with behaviour change techniques guided by the Health Action Process Approach model, or the control group (n = 30), receiving regular health talks. Individual semi-structured interviews were conducted with 21 experimental group participants to determine the barriers and facilitators of dietary behaviour changes after the intervention.ResultsThe feasibility of the DBC intervention was confirmed by an acceptable recruitment rate (57.14%) and a good retention rate (83.33%). Compared with the control group, the experimental group significantly reduced their body weight (p = 0.027, d = 1.22) and improved their dietary quality (p < 0.001, d = 1.31). A positive improvement in handgrip strength (from 15.37 ± 1.08 kg to 18.21 ± 1.68 kg), waist circumference (from 99.28 ± 1.32 cm to 98.42 ± 1.39 cm), and gait speed (from 0.91 ± 0.02 m/s to 0.99 ± 0.03 m/s) was observed only in the experimental group. However, the skeletal muscle mass index in the experimental group decreased. The interview indicated that behaviour change techniques enhanced the partcipants' compliance with their dietary regimen, while cultural contextual factors (e.g., family dining style) led to some barriers.ConclusionThe DBC intervention could reduce body weight, and has positive trends in managing handgrip strength, gait speed, and waist circumference. Interestingly, the subtle difference between the two groups in the change of muscle mass index warrants futures investigation. This study demonstrated the potential for employing dietary behaviour change interventions in community healthcare.Trial registrationRegistered retrospectively on ClinicalTrailas.gov (31/12/2020, NCT04690985).

Dataset Information

Dietary supplements for aggressive behaviour in people with intellectual disabilities: A randomised controlled crossover trial.

Background

Methods

Results

Conclusion

Publications

Dietary supplements for aggressive behaviour in people with intellectual disabilities: A randomised controlled crossover trial.

Similar Datasets

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