Palatability Assessment of 3D-printed Chewable Tablets in Children and AdolescentsACEITA3DNCT07424495
Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents
An observational study of Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents, run by University of Brasilia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Dec 2028
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Child, Adult
Study population: Children and adolescents receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar.
Who may be able to join
- Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar (HCB).
- Written informed consent provided by the legal guardian through the signing of the Informed Consent Form (ICF).
- Assent from the child or adolescent, when applicable, expressed through the signing of the Informed Assent Form (IAF).
Who cannot join
- Children or adolescents with dietary restrictions or known allergies to any component present in the formulations used in the study.
- Children or adolescents with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Children or adolescents diagnosed with severe neurological, cognitive, or behavioral disorders that impair communication, comprehension, or response to the sensory scale.
- Oral conditions, mucosal lesions, or dysphagia that prevent or significantly impair proper chewing or swallowing of the tablet (e.g., mucositis).
- Refusal of the child/adolescent or legal guardian to participate in the study at any time, even after prior consent has been provided.
About this study
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.
- Keywords
- Palatability, 3D Printing, Chewable Tablet, Pediatric Formulation, Sensory Acceptability, Pharmaceutical Technology
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after tablet administration (single assessment per stage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Palatability Assessment of 3D-printed Chewable Tablets in Children and AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital da Criança de Brasília José Alencar
- Responsible party
- Principal investigator, Marcílio Sérgio Soares da Cunha Filho, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424495
- Sponsor's protocol ID
- ACEITA3D
- Acronym
- ACEITA3D
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
Publications
Lajoinie A, Janiaud P, Henin E, Gleize J-C, Berlion C, Nguyen KA, Nony P, Gueyffier F, Maucort-Boulch D, Kassaï Koupaï B. Assessing the effects of solid versus liquid dosage forms of oral medications on adherence and acceptability in children. Cochrane Database of Systematic Reviews 2017, Issue 9. Art. No.: CD012783. DOI: 10.1002/14651858.CD012783.
Abdel-Rahman SM, Bai S, Porter-Gill PA, Goode GA, Kearns GL. A Pilot Comparison of High- Versus Low-Tech Palatability Assessment Tools in Young Children. Paediatr Drugs. 2021 Jan;23(1):95-104. doi: 10.1007/s40272-020-00430-2. Epub 2020 Nov 25.
PubMed 33236188Mistry P, Stirling H, Callens C, Hodson J, Batchelor H; SPaeDD-UK project. Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population. BMJ Open. 2018 Jul 11;8(7):e021961. doi: 10.1136/bmjopen-2018-021961.
PubMed 29997143van Riet-Nales DA, de Neef BJ, Schobben AF, Ferreira JA, Egberts TC, Rademaker CM. Acceptability of different oral formulations in infants and preschool children. Arch Dis Child. 2013 Sep;98(9):725-31. doi: 10.1136/archdischild-2012-303303. Epub 2013 Jul 13.
PubMed 23853004
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents
- ClinicalTrials.gov ID
- NCT07424495
- Acronym / sponsor ID
- ACEITA3D / ACEITA3D
- Keywords
- Palatability, 3D Printing, Chewable Tablet, Pediatric Formulation, Sensory Acceptability, Pharmaceutical Technology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Hospital da Criança de Brasília José Alencar
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and adolescents receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar.
Key inclusion criteria (3 listed)
- Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar (HCB).
- Written informed consent provided by the legal guardian through the signing of the Informed Consent Form (ICF).
- Assent from the child or adolescent, when applicable, expressed through the signing of the Informed Assent Form (IAF).
Key exclusion criteria (5 listed)
- Children or adolescents with dietary restrictions or known allergies to any component present in the formulations used in the study.
- Children or adolescents with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Children or adolescents diagnosed with severe neurological, cognitive, or behavioral disorders that impair communication, comprehension, or response to the sensory scale.
- Oral conditions, mucosal lesions, or dysphagia that prevent or significantly impair proper chewing or swallowing of the tablet (e.g., mucositis).
- Refusal of the child/adolescent or legal guardian to participate in the study at any time, even after prior consent has been provided.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory acceptability score (5-point facial hedonic scale)
Time frame: Immediately after tablet administration (single assessment per stage)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- BackgroundLajoinie A, Janiaud P, Henin E, Gleize J-C, Berlion C, Nguyen KA, Nony P, Gueyffier F, Maucort-Boulch D, Kassaï Koupaï B. Assessing the effects of solid versus liquid dosage forms of oral medications on adherence and acceptability in children. Cochrane Database of Systematic Reviews 2017, Issue 9. Art. No.: CD012783. DOI: 10.1002/14651858.CD012783.
- Background: PubMed 33236188Abdel-Rahman SM, Bai S, Porter-Gill PA, Goode GA, Kearns GL. A Pilot Comparison of High- Versus Low-Tech Palatability Assessment Tools in Young Children. Paediatr Drugs. 2021 Jan;23(1):95-104. doi: 10.1007/s40272-020-00430-2. Epub 2020 Nov 25.
- Background: PubMed 29997143Mistry P, Stirling H, Callens C, Hodson J, Batchelor H; SPaeDD-UK project. Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population. BMJ Open. 2018 Jul 11;8(7):e021961. doi: 10.1136/bmjopen-2018-021961.
- Background: PubMed 23853004van Riet-Nales DA, de Neef BJ, Schobben AF, Ferreira JA, Egberts TC, Rademaker CM. Acceptability of different oral formulations in infants and preschool children. Arch Dis Child. 2013 Sep;98(9):725-31. doi: 10.1136/archdischild-2012-303303. Epub 2013 Jul 13.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents, run by University of Brasilia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory acceptability score (5-point facial hedonic scale) (time frame: Immediately after tablet administration (single assessment per stage)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07424495, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.