NCT07795190

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Feb 2028

First Submitted

Initial submission to the registry

August 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 23, 2026

Last Update Submit

August 26, 2026

Conditions

Chronic Kidney Disease

Keywords

Nutritional managementHealth statusFunctional capacityChronic kidney diseas

Outcome Measures

Primary Outcomes (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.

    One year

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 33730284RESULT

  • 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.

    PMID: 31667620RESULT

  • 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.

    PMID: 41251793RESULT

  • 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.

    PMID: 31845057RESULT

  • 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.

    PMID: 40556501RESULT

  • 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.

    PMID: 33754509RESULT

  • 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.

    PMID: 38629745RESULT

  • 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.

    PMID: 36771235RESULT

  • 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.

    PMID: 32829751RESULT

  • 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.

    PMID: 38985211RESULT

  • 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.

    PMID: 35378603RESULT

  • 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.

    PMID: 40799078RESULT

  • 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.

    PMID: 38490803RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Osama M Elasher, Professor

    Assiut university Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Th Attia, Assistant lecturer

CONTACT

020 1270735221martinatharwat@aun.edu.eg

Noha M Gamal, Lecturer

CONTACT

020 1010321034nmgped@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of pediatrics

Study Record Dates

First Submitted

August 23, 2026

First Posted

August 31, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

August 31, 2026

Record last verified: 2026-08