NL-OMON49773CompletedNot Applicable
Vitamins and Nutrients as Supplementation for Irritability (VANTASTIC Study) - A Double-blind Randomized Placebo-Controlled Trial - VANTASTIC Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 17 (—)
Inclusion Criteria
- •Aged 11;0-17; 6 years
- •Presence of a high level of irritability based on an Affective Reactivity
- •Index (ARI) score >= 5 according to parent report.
- •Presence or absence of ADHD in a ratio of 2:1. Those without ADHD may have
- •any behavioral or emotional disorder (such as ODD, CD, and any affective
- •disorder). All types of comorbidities are allowed.
Exclusion Criteria
- •Subject is in the opinion of the investigator not able to comply with study
- •proce-dures, such as swallowing capsules; or if participation in this study may
- •pose a safety risk.
- •Intellectual disability (based on available IQ below 70 or the clinical
- •opinion of the investigator, taking into account relevant psychosocial
- •information, e.g. educa-tional level; or as confirmed by obtained IQ during the
- •optional cognitive meas-urements)
- •Any known abnormality of mineral metabolism (e.g., Wilson*s disease,
- •haemo-chromatosis)
- •Subject has a documented allergy, hypersensitivity, or intolerance to any of
- •the in-gredients of the investigational product
- •Subjects with diabetes mellitus (type 1 or 2) cannot take part in the
- •microbiome measurements.
- •Subject has taken another nutritional supplement product or taken part in a
- •clinical study within 30 days prior to entering the study
- •Subject is receiving ongoing psychosocial treatment
Investigators
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