Nutritional Assessment of Children With Chronic Kidney Disease

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04584905
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition Disorders, Child	Dietary Supplement: dietary supplements for CKD patients

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

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Nutritional Assessment of Children With Chronic Kidney Disease Attending Assuit University Children Hospital
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 30, 2021

Outcome Measures

Primary Outcome Measures

1. Assessment of nutritional status of children with CKD. [from January 2021 to June 2021]

   by measuring body mass index in kg/m2.

Secondary Outcome Measures

1. Assess STAMP screening tool [from January 2021 to June 2021]

   Five steps STAMP assessment for detection of malnutrition in children with CKD.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Universty Hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maram Mohamed Amir Fathy, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04584905
• Other Study ID Numbers: nutrition in CKD
• First Posted: Oct 14, 2020
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maram Mohamed Amir Fathy, principal investigator, Assiut University: chronic kidney disease
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Nutrition Disorders; Child Nutrition Disorders

Study Results

No Results Posted as of Jun 3, 2021