Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.

NCT06268314 | Not Yet Recruiting

• 1 other identifier: hypoalbuminemia in pediatrics.
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.

  Feeding pattern has important role on improving hypoalbuminemia in pediatrics with chronic renal disease Based on determining the main outcome variable ,the estimated minimum required sample size is77. The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is the role of feeding in treating hypoalbuminemia in pediatric patients with CKD . Based on previous studies ( O.S. Catherine. et al. 2002 ) the percentage of patients of chronic kidney disease with hypoalbuminemia53.1% and based on the percentage confidence limits of 7% and a Confidence level =80

  2years

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Based on determining the main outcome variable ,the estimated minimum required sample size is77. The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is the role of feeding in treating hypoalbuminemia in pediatric patients with CKD . Based on previous studies ( O.S. Catherine. et al. 2002 ) the percentage of patients of chronic kidney disease with hypoalbuminemia53.1% and based on the percentage confidence limits of 7% and a Confidence level =80

You may qualify if:

• The study will include patient on maintenance hemodialysis with hypoalbuminemia according to\] Mites SedBuffone GJed Pediatric Clinical Chemistry. 3rd ed., Press(1989)\[ (Hypoalbuminemia was defined as an albumin level of less than 3.4 g/dL for patients 7 months or older and less than 2.5 g/dL for patients younger than 7 months. ) who fulfilled the following criteria will be included in the study:
• Age range from 2-16 years old.
• Both sexes.
• On maintenance hemodialysis with hypoalbuminemia

You may not qualify if:

• other causes of hypoalbuminemia such as heart disease, diabetes mellitus , hepatic failure .
• chronic kidney disease without hypoalbuminemia.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Kalantar-Zadeh K, Cano NJ, Budde K, Chazot C, Kovesdy CP, Mak RH, Mehrotra R, Raj DS, Sehgal AR, Stenvinkel P, Ikizler TA. Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat Rev Nephrol. 2011 May 31;7(7):369-84. doi: 10.1038/nrneph.2011.60.

  PMID: 21629229 BACKGROUND

• Palmer SC, Maggo JK, Campbell KL, Craig JC, Johnson DW, Sutanto B, Ruospo M, Tong A, Strippoli GF. Dietary interventions for adults with chronic kidney disease. Cochrane Database Syst Rev. 2017 Apr 23;4(4):CD011998. doi: 10.1002/14651858.CD011998.pub2.

  PMID: 28434208 BACKGROUND

• Iseki K, Uehara H, Nishime K, Tokuyama K, Yoshihara K, Kinjo K, Shiohira Y, Fukiyama K. Impact of the initial levels of laboratory variables on survival in chronic dialysis patients. Am J Kidney Dis. 1996 Oct;28(4):541-8. doi: 10.1016/s0272-6386(96)90465-5.

  PMID: 8840944 BACKGROUND

• Wong CS, Hingorani S, Gillen DL, Sherrard DJ, Watkins SL, Brandt JR, Ball A, Stehman-Breen CO. Hypoalbuminemia and risk of death in pediatric patients with end-stage renal disease. Kidney Int. 2002 Feb;61(2):630-7. doi: 10.1046/j.1523-1755.2002.00169.x.

  PMID: 11849406 BACKGROUND

• Rees L, Mak RH. Nutrition and growth in children with chronic kidney disease. Nat Rev Nephrol. 2011 Sep 27;7(11):615-23. doi: 10.1038/nrneph.2011.137.

  PMID: 21947116 BACKGROUND

• Silverstein DM. Inflammation in chronic kidney disease: role in the progression of renal and cardiovascular disease. Pediatr Nephrol. 2009 Aug;24(8):1445-52. doi: 10.1007/s00467-008-1046-0. Epub 2008 Dec 13.

  PMID: 19083024 BACKGROUND

• Rees L. 3.21 Nutritional management in children with chronic kidney disease. World Rev Nutr Diet. 2015;113:254-8. doi: 10.1159/000360347. Epub 2015 Apr 13. No abstract available.

  PMID: 25906893 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Elmenshawy

  Assist university

  STUDY DIRECTOR

Central Study Contacts

Mohamed Abdelguad, Resident

CONTACT

01023751005; ataay411@gmail.com

Azaa Eltayib, Professor

CONTACT

‪0100 686 3277‬

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-03