- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335368
Assessment of Nutritional and Growth Status in Rett Syndrome Patients
March 27, 2024 updated by: National Taiwan University Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Rett syndrome patient.
Description
Inclusion Criteria:
- Rett syndrome patient.
Exclusion Criteria:
- Not Rett syndrome patient.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gender, age , disease history checklist
Time Frame: 1 year
|
1 year
|
|
|
Change in Body height
Time Frame: 1 year
|
The growth status of the case will be assessed
|
1 year
|
|
Change in Body weight
Time Frame: 1 year
|
The growth status of the case will be assessed
|
1 year
|
|
Change in knee height
Time Frame: 1 year
|
The growth status of the case will be assessed
|
1 year
|
|
Change in arms height
Time Frame: 1 year
|
The growth status of the case will be assessed and growth curve
|
1 year
|
|
Change in waist
Time Frame: 1 year
|
The growth status of the case will be assessed
|
1 year
|
|
Change in hip circumferences
Time Frame: 1 year
|
The growth status of the case will be assessed
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2016
Primary Completion (Actual)
May 23, 2016
Study Completion (Actual)
October 26, 2020
Study Registration Dates
First Submitted
July 21, 2022
First Submitted That Met QC Criteria
March 27, 2024
First Posted (Actual)
March 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201512178RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Assessment of nutritional and growth status in Rett syndrome patient
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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