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AzTrials

Chronic Kidney DiseaseNCT07795190

Targeted Nutritional Management for Children With Chronic Kidney Disease

An observational study of Chronic Kidney Disease, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To assess the effect of various nutritional interventions including the use of specific milk formulas on healthy status, growth parameters, body composition, skeletal muscle mass and functional capacity in patients with chronic kidney disease. Read more about this study

Who is it for?
Ages 6 months to 12 years
Conditions the study is for
Chronic Kidney Disease
How many people
128 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 28 Feb 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 6 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: School age children with CKD from 6_12 years with all stages of CKD according to KDIGO classification

Who may be able to join

  • The school age children with CKD aged from 6 years up to 12 years old.
  • All stages of CKD according to KDIGO classification -

Who cannot join

  • patients below 6 years or over than 12 years old.
  • patients aren't adherent to nutritional instructions.
  • Presence of any other disease. -

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Martina Th Attia, Assistant lecturer contact

020 1270735221

martinatharwat@aun.edu.eg

Noha M Gamal, Lecturer contact

020 1010321034

nmgped@aun.edu.eg

About this study

Official title: Targeted Nutritional Management for Children With Chronic Kidney Disease and Its Impact on Their Health Status and Functional Capacity

To assess the effect of various nutritional interventions including the use of specific milk formulas on healthy status, growth parameters, body composition, skeletal muscle mass and functional capacity in patients with chronic kidney disease.

Read the 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.

Keywords
Nutritional management, Health status, Functional capacity, Chronic kidney diseas
Medical subject headings
Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Targeted nutritional management for children with chronic kidney disease and its impact on their health status and functional capacity

    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.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07795190
Sponsor's protocol ID
Nutrition in children with CKD
Status last verified
Aug 2026
First submitted
23 Aug 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33730284
  • 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.

    PubMed 31667620
  • 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.

    PubMed 41251793
  • 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.

    PubMed 31845057
  • 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.

    PubMed 40556501
  • 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.

    PubMed 33754509
  • 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.

    PubMed 38629745
  • 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.

    PubMed 36771235
  • 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.

    PubMed 32829751
  • 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.

    PubMed 38985211
  • 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.

    PubMed 35378603
  • 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.

    PubMed 40799078
  • 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.

    PubMed 38490803

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease, run by Assiut University.

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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martina Th Attia, Assistant lecturer (020 1270735221, martinatharwat@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Targeted nutritional management for children with chronic kidney disease and its impact on their health status and functional capacity (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07795190, which also lists 13 linked publications.

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 31 Aug 2026.

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