Nutrition Disorders, ChildNCT04584905
Nutritional Assessment of Children With Chronic Kidney Disease
An observational study of Nutrition Disorders, Child, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders, Child
- What is being tested?
- dietary supplements for CKD patients
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Dec 2021
- 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 2 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children of both sexes. Diagnosed as chronic kidney disease. Age: 2 years up to 15 Years Children
Who may be able to join
- Children of both sexes.
- Diagnosed as chronic kidney disease.
- Age: 2 years up to 15 Years Children.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Universty Hospital
Asyut
maram M amir, resident, 01014808876, maramamir1994@yahoo.com
About this study
Official title: 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.
Read the 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 .
- Conditions
- Nutrition Disorders, Child
- Being tested
- dietary supplements for CKD patients
- Keywords
- chronic kidney disease
- Medical subject headings
- Child Nutrition Disorders, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplements for CKD patientsDietary supplement
follow up and assessment of nutritional status of CKD patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of nutritional status of children with CKD.
by measuring body mass index in kg/m2.
Measured: from January 2021 to June 2021
Secondary outcomes (1)
Assess STAMP screening tool
Five steps STAMP assessment for detection of malnutrition in children with CKD.
Measured: from January 2021 to June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jan 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Disorders, ChildStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Mohamed Amir Fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584905
- Sponsor's protocol ID
- nutrition in CKD
- Status last verified
- May 2021
- First submitted
- 23 Sep 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment of Children With Chronic Kidney Disease Attending Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT04584905
- Acronym / sponsor ID
- nutrition in CKD
- Conditions
- Nutrition Disorders, Child
- Keywords
- chronic kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 14 Oct 2020 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children of both sexes. Diagnosed as chronic kidney disease. Age: 2 years up to 15 Years Children
Key inclusion criteria (3 listed)
- Children of both sexes.
- Diagnosed as chronic kidney disease.
- Age: 2 years up to 15 Years Children.
Key exclusion criteria (4 listed)
- • Age: less than 2 years old child and more than 15 years old child.
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 |
|---|---|---|
| dietary supplements for CKD patientsfollow up and assessment of nutritional status of CKD patients | Dietary supplement | – |
Primary outcome
Assessment of nutritional status of children with CKD.
Time frame: from January 2021 to June 2021
by measuring body mass index in kg/m2.
1 secondary outcome
Assess STAMP screening tool
Time frame: from January 2021 to June 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders, Child, run by Assiut University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maram mohamed amir, resident doctor (01014808876, Maramamior1994@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of nutritional status of children with CKD. (time frame: from January 2021 to June 2021). 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 3 Jun 2021.