- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07795190
Targeted Nutritional Management for Children With Chronic Kidney Disease
Targeted Nutritional Management for Children With Chronic Kidney Disease and Its Impact on Their Health Status and Functional Capacity
Study Overview
Status
Conditions
Detailed Description
The Kidney Disease Improving Global Outcomes (KDIGO) 2024 defined the chronic kidney disease as abnormalities of kidney structure or function, present for a minimum of 3 months, with implications for health. CKD is classified based on Cause, Glomerular filtration rate (GFR) category (G1-G5), and Albuminuria category (A1-A3).
Nutritional management of pediatric patients with kidney disease is challenging as they undergo continued growth and development. So providing adequate nutrition for growth while minimizing disease progression and complications is the primary challenge.
There are many reasons for poor growth in children with (CKD), One of the most important of these is inadequate nutritional intake which may be due to anorexia, which is common in CKD, gastro-esophageal reflux with recurrent vomiting. The consequences of poor nutrition in children are suboptimal growth and impaired achievement of final height potential, abnormal body composition, developmental delay, a worsening of uremic symptoms such as vomiting, protein-energy wasting, and increased mortality.
optimizing the dietary prescription for the child with CKD is of vital importance at any age to promote growth and reverse growth failure if present.
During progression of chronic kidney disease, the requirements and utilization of different nutrients change significantly. These changes ultimately place patients with kidney disease at higher risk for nutritional and metabolic abnormalities so regular assessment of nutritional status and provision of suitable nutrition are key parts in the overall management of children with CKD aiming at preventing protein-energy malnutrition, meeting the patient's micronutrients needs and preventing overnutrition and the long-term implications of an undesirable eating routine.
unbalanced dietary pattern, characterized by high animal protein content: may worsen metabolic control, accelerate renal deterioration and consequently aggravate the stage of the chronic kidney disease in pediatric patients.
CKD is associated with chronic low-grade inflammation causing catabolic destruction of structural and functional proteins, resulting in skeletal muscle wasting, leading to progressive weight loss, muscle weakness in children resulting in a decrease in functional capacity.
Patients with advanced CKD are at high risk of cardiovascular disease (CVD). Complex changes in both the cardiac and vascular systems results in structural and functional changes that can lead to reduced exercise tolerance, quality of life and ultimately premature death.
A multidisciplinary team should consistently communicate the same messages about nutrition to provide support to the family. Educational resources, whether verbal, written, pictorial, or digital, must be adapted to suit the learning style of the child and family so that they understand the need for any nutritional interventions. This understanding, in turn, will lead to better adherence and improved outcomes for the child with CKD.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Martina Th Attia, Assistant lecturer
- Phone Number: 020 1270735221
- Email: martinatharwat@aun.edu.eg
Study Contact Backup
- Name: Noha M Gamal, Lecturer
- Phone Number: 020 1010321034
- Email: nmgped@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- The school age children with CKD aged from 6 years up to 12 years old.
- All stages of CKD according to KDIGO classification -
Exclusion Criteria:
- patients below 6 years or over than 12 years old.
- patients aren't adherent to nutritional instructions.
- Presence of any other disease. -
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Targeted nutritional management for children with chronic kidney disease and its impact on their health status and functional capacity
Time Frame: One year
|
optimizing the dietary prescription for the children with CKD to promote growth and reverse growth failure if present aiming at preventing protein-energy malnutrition, meeting the patient's micronutrients needs and preventing overnutrition and the long-term implications of an undesirable eating routine.
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Osama M Elasher, Professor, Assiut university Children's Hospital
Publications and helpful links
General Publications
- Ikizler TA, Burrowes JD, Byham-Gray LD, Campbell KL, Carrero JJ, Chan W, Fouque D, Friedman AN, Ghaddar S, Goldstein-Fuchs DJ, Kaysen GA, Kopple JD, Teta D, Yee-Moon Wang A, Cuppari L. KDOQI Clinical Practice Guideline for Nutrition in CKD: 2020 Update. Am J Kidney Dis. 2020 Sep;76(3 Suppl 1):S1-S107. doi: 10.1053/j.ajkd.2020.05.006.
- Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
- Desloovere A, Renken-Terhaerdt J, Tuokkola J, Shaw V, Greenbaum LA, Haffner D, Anderson C, Nelms CL, Oosterveld MJS, Paglialonga F, Polderman N, Qizalbash L, Warady BA, Shroff R, Vande Walle J. The dietary management of potassium in children with CKD stages 2-5 and on dialysis-clinical practice recommendations from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol. 2021 Jun;36(6):1331-1346. doi: 10.1007/s00467-021-04923-1. Epub 2021 Mar 17.
- McAlister L, Pugh P, Greenbaum L, Haffner D, Rees L, Anderson C, Desloovere A, Nelms C, Oosterveld M, Paglialonga F, Polderman N, Qizalbash L, Renken-Terhaerdt J, Tuokkola J, Warady B, Walle JV, Shaw V, Shroff R. The dietary management of calcium and phosphate in children with CKD stages 2-5 and on dialysis-clinical practice recommendation from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol. 2020 Mar;35(3):501-518. doi: 10.1007/s00467-019-04370-z. Epub 2019 Oct 30.
- Renken-Terhaerdt J, Desloovere A, Oosterveld MJ, Polderman N, Snauwaert E, Stabouli S, Walle JV, Anderson C, Collins S, Greenbaum LA, Harmer M, Harshman L, Nelms CL, Pugh P, Shaw V, Tuokkola J, Vega MRW, Warady BA, Shroff R, Paglialonga F. The dietary management of sodium in children with kidney diseases-clinical practice recommendations from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol. 2026 May;41(5):1535-1556. doi: 10.1007/s00467-025-06913-z. Epub 2025 Nov 18.
- Shaw V, Polderman N, Renken-Terhaerdt J, Paglialonga F, Oosterveld M, Tuokkola J, Anderson C, Desloovere A, Greenbaum L, Haffner D, Nelms C, Qizalbash L, Vande Walle J, Warady B, Shroff R, Rees L. Energy and protein requirements for children with CKD stages 2-5 and on dialysis-clinical practice recommendations from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol. 2020 Mar;35(3):519-531. doi: 10.1007/s00467-019-04426-0. Epub 2019 Dec 16.
- Zapata KA, Cooksey RH, Fulton DK, Shelton HB, Jo CH, Adams RC. Six-minute walk test reference values in ambulatory children with myelomeningocele. Dev Med Child Neurol. 2026 Jan;68(1):110-117. doi: 10.1111/dmcn.16397. Epub 2025 Jun 25.
- Cha RH, Lee GS, Yoo JY, Rhee OB, Jeon YD. Hand Grip and Leg Muscle Strength in Hemodialysis Patients and Its Determinants. J Korean Med Sci. 2021 Mar 22;36(11):e76. doi: 10.3346/jkms.2021.36.e76.
- Goswami H, Shah H, Vala K, Kapadia S, Tiwari B, Saha A. Physical functional capacity assessment in children with chronic kidney disease: A cross sectional observational study. Clin Nephrol. 2024 Jul;102:8-15. doi: 10.5414/CN111295.
- Suarez-Gonzalez M, Ordonez-Alvarez FA, Gil-Pena H, Carnicero-Ramos S, Hernandez-Pelaez L, Garcia-Fernandez S, Santos-Rodriguez F. Nutritional Assessment and Support in Children with Chronic Kidney Disease: The Benefits of Working with a Registered Dietitian. Nutrients. 2023 Jan 19;15(3):528. doi: 10.3390/nu15030528.
- Shaw V, Anderson C, Desloovere A, Greenbaum LA, Harshman L, Nelms CL, Pugh P, Polderman N, Renken-Terhaerdt J, Snauwaert E, Stabouli S, Tuokkola J, Vande Walle J, Warady BA, Paglialonga F, Shroff R. Nutritional management of the child with chronic kidney disease and on dialysis. Pediatr Nephrol. 2025 Jan;40(1):69-84. doi: 10.1007/s00467-024-06444-z. Epub 2024 Jul 10.
- Shaw V, Anderson C, Desloovere A, Greenbaum LA, Haffner D, Nelms CL, Paglialonga F, Polderman N, Qizalbash L, Renken-Terhaerdt J, Stabouli S, Tuokkola J, Vande Walle J, Warady BA, Shroff R. Nutritional management of the infant with chronic kidney disease stages 2-5 and on dialysis. Pediatr Nephrol. 2023 Jan;38(1):87-103. doi: 10.1007/s00467-022-05529-x. Epub 2022 Apr 5.
- Ahn YH, Kang HG, Song J, Han S, Park E, Suh JS, Kim JY, Park MJ, Lee KH, Lim SH, Shin KH, Ko H, Lee HJ, Jeong E, Kim J, Park S, Choi E, Seo Y, Oh K, Kim JK, Lee HK. Dietary management of pediatric patients with kidney disease: recommendations by The Korean Society of Pediatric Nephrology and The Korean Society of Clinical Nutrition. Kidney Res Clin Pract. 2025 Nov;44(6):863-874. doi: 10.23876/j.krcp.25.114. Epub 2025 Jul 30.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- Nutrition in children with CKD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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