- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04584905
Nutritional Assessment of Children With Chronic Kidney Disease
May 31, 2021 updated by: Maram Mohamed Amir Fathy, Assiut University
Nutritional Assessment of Children With Chronic Kidney Disease Attending Assuit University Children Hospital
Primary outcome is assessment of nutritional status of children with CKD.
Secondary outcome is assessment STAMP screening tool for detection of malnutrition of CKD children.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Pediatric Chronic Kidney Disease (CKD) has systemic implication on all aspects of normal development, including nutrition, growth, bone and mineral metabolism and neurocognitive function .
Chronic Kidney Disease (CKD) introduces a unique set of nutritional challenges for the growing and developing child .
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: maram mohamed amir, resident doctor
- Phone Number: 01014808876
- Email: Maramamior1994@yahoo.com
Study Contact Backup
- Name: mohamed A AbdelMoez, prof
- Phone Number: 01005208016
- Email: abdellatefabdelmoez@yahoo.com
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Assiut universty Hospital
-
Contact:
- maram M amir, resident
- Phone Number: 01014808876
- Email: maramamir1994@yahoo.com
-
-
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
2 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children of both sexes.
Diagnosed as chronic kidney disease.
Age: 2 years up to 15 Years Children
Description
Inclusion Criteria:
- Children of both sexes.
- Diagnosed as chronic kidney disease.
- Age: 2 years up to 15 Years Children.
Exclusion Criteria:
• Age: less than 2 years old child and more than 15 years old child.
- Previously diagnosed to have any co- morbid or systemic disease other than CKD.
- Irregular dialysis.
- Renal transplant.
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of nutritional status of children with CKD.
Time Frame: from January 2021 to June 2021
|
by measuring body mass index in kg/m2.
|
from January 2021 to June 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess STAMP screening tool
Time Frame: from January 2021 to June 2021
|
Five steps STAMP assessment for detection of malnutrition in children with CKD.
|
from January 2021 to June 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 30, 2021
Study Registration Dates
First Submitted
September 23, 2020
First Submitted That Met QC Criteria
October 10, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
June 3, 2021
Last Update Submitted That Met QC Criteria
May 31, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- nutrition in CKD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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