An observational study in Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents, sponsored by University of Brasilia. Not yet recruiting. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by University of Brasilia · Observational
The lack of appropriate pediatric formulations compromises adherence and the effectiveness of oral treatment in children, mainly due to the splitting of adult tablets and low sensory acceptability. This observational, analytical, and cross-sectional study aims to evaluate the acceptability of a novel pediatric dosage form consisting of placebo chewable tablets produced by 3D printing, with a focus on palatability and feasibility for dose personalization. Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar will be invited to participate. The study will be conducted in two stages. In the first stage, acceptability of a bear-shaped chewable tablet will be assessed, as well as preference among different flavors. In the second stage, preference for chewable tablets with or without xylitol will be investigated, in addition to dysgeusia associated with diseases or chronic medication use. Acceptability will be measured using a 5-point facial hedonic scale, evaluator observation, and age-appropriate questionnaires. The study is expected to identify the most accepted flavors and sweetness intensities, as well as to evaluate the acceptability of the 3D-printed dosage form, contributing to the development of safer, more attractive, and personalized pediatric medicines.
University of Brasilia is the lead sponsor of 66 studies on the registry; 12 are open to participants now.
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Children and adolescents receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sensory acceptability score (5-point facial hedonic scale)
Sensory acceptability will be assessed using a 5-point Facial Hedonic Scale ranging from 1 (disliked very much) to 5 (liked very much), with higher scores indicating better acceptability.
Time frame: Immediately after tablet administration (single assessment per stage)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Brasilia