Rett SyndromeNCT06335368
Assessment of Nutritional and Growth Status in Rett Syndrome Patients
An observational study of Rett Syndrome and Neurologic Disorder, run by National Taiwan University Hospital.
Trial summary
Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Rett Syndrome, Neurologic Disorder
- What is being tested?
- Nutrition and Growth Status
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2016to 26 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Rett syndrome patient.
Who may be able to join
- Rett syndrome patient.
Who cannot join
- Not Rett syndrome patient.
About this study
Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan.
- Conditions
- Rett Syndrome, Neurologic Disorder
- Being tested
- Nutrition and Growth Status
- Medical subject headings
- Rett Syndrome, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Growth StatusOther
Nutrition and Growth Status
What is being measured
The primary outcome is the main question the study is designed to answer.
gender, age , disease history checklist
Measured: 1 year
Change in Body height
The growth status of the case will be assessed
Measured: 1 year
Change in Body weight
The growth status of the case will be assessed
Measured: 1 year
Change in knee height
The growth status of the case will be assessed
Measured: 1 year
Change in arms height
The growth status of the case will be assessed and growth curve
Measured: 1 year
Change in waist
The growth status of the case will be assessed
Measured: 1 year
Change in hip circumferences
The growth status of the case will be assessed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start9 Mar 2016
- Primary completion23 May 2016
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335368
- Sponsor's protocol ID
- 201512178RINC
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Assessment of nutritional and growth status in Rett syndrome patient
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional and Growth Status in Rett Syndrome Patients
- ClinicalTrials.gov ID
- NCT06335368
- Acronym / sponsor ID
- 201512178RINC
- Conditions
- Rett Syndrome, Neurologic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 23 May 2016 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 28 Mar 2024 (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.
Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Rett syndrome patient.
Key inclusion criteria (1 listed)
- Rett syndrome patient.
Key exclusion criteria (1 listed)
- Not Rett syndrome patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and Growth StatusNutrition and Growth Status | Other | – |
Primary outcome
gender, age , disease history checklist
Time frame: 1 year
Change in Body height
Time frame: 1 year
The growth status of the case will be assessed
Change in Body weight
Time frame: 1 year
The growth status of the case will be assessed
Change in knee height
Time frame: 1 year
The growth status of the case will be assessed
Change in arms height
Time frame: 1 year
The growth status of the case will be assessed and growth curve
Change in waist
Time frame: 1 year
The growth status of the case will be assessed
Change in hip circumferences
Time frame: 1 year
The growth status of the case will be assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No. Assessment of nutritional and growth status in Rett syndrome patient
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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. This study is not recruiting at the moment.
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 Rett Syndrome and Neurologic Disorder, run by National Taiwan University Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
gender, age , disease history checklist (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2024.