Chronic Kidney DiseasesNCT06268314
Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.
An observational study of Chronic Kidney Diseases, run by Assiut University.
Trial summary
To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 16 years
- All sexes
- Child
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
Who may be able to join
- 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
Who cannot join
- other causes of hypoalbuminemia such as heart disease, diabetes mellitus , hepatic failure .
- chronic kidney disease without hypoalbuminemia.
Trial locations and contacts
No sites are listed yet.
Azaa Eltayib, Professor contact
About this study
To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease.
Read the detailed description
Chronic kidney disease (CKD) is characterized by an irreversible deterioration of renal function that gradually progresses to end-stage renal disease. During the past 2 decades, the incidence of CKD in children has steadily increased.Children, adolescents, and young adults constitute less than 5% of the end-s population, and their 10-year survival ranges from 70% to 85%.Although children represent only a small proportion of all patients with CKD, affected children pose unique challenges to the health care system and to their providers, who must address not only the primary renal disorder, but the many extrarenal manifestations of CKD that complicate management.Serum albumin is a strong predictor for adverse outcomes in adults with chronic kidney disease (CKD). Because these conditions are amenable to treatments, recognition of hypoalbuminemia and underlying status may improve patient management, potentially leading to better clinical outcomes.Hypoalbuminemia is known to be an independent predictor of survival and hospitalization in adult patients with end-stage renal disease (ESRD) on dialysis.In children with ESRD, a few studies have focused on mortality or hospitalization as outcomes, showing the association of hypoalbuminemia with high mortality in incident dialysis patients and high hospitalization frequency in prevalent dialysis patients.Further, patients with chronic diseases and hypoalbuminemia lose fat-free mass, considered to be an essential indicator of the undernourished state, despite adequate food intake.Protein energy wasting (PEW) is common in patients with CKD and associated with adverse clinical Outcomes .(PEW) is closely associated with malnutrition and inflammation, where serum albumin is an established surrogate biomarker.
Children with CKD are also at high risk of poor nutrition and chronic inflammation .Malnutrition and inflammation are associated with adverse outcomes such as death or hospitalization.Furthermore, among children with CKD, inadequate nutrition is one of the most common causes of growth failure, resulting in short stature or low body mass index (BMI)which is also associated with death or hospitalization.
- Conditions
- Chronic Kidney Diseases
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Abdel-Gawad, Assiut University
- Investigators
- Ahmed Elmenshawy, Study director, Assist university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268314
- Sponsor's protocol ID
- hypoalbuminemia in pediatrics.
- Status last verified
- Mar 2024
- First submitted
- 25 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21629229Palmer 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.
PubMed 28434208Iseki 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.
PubMed 8840944Wong 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.
PubMed 11849406Rees 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.
PubMed 21947116Silverstein 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.
PubMed 19083024Rees 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.
PubMed 25906893
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT06268314
- Acronym / sponsor ID
- hypoalbuminemia in pediatrics.
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease.
Detailed description
Chronic kidney disease (CKD) is characterized by an irreversible deterioration of renal function that gradually progresses to end-stage renal disease. During the past 2 decades, the incidence of CKD in children has steadily increased.Children, adolescents, and young adults constitute less than 5% of the end-s population, and their 10-year survival ranges from 70% to 85%.Although children represent only a small proportion of all patients with CKD, affected children pose unique challenges to the health care system and to their providers, who must address not only the primary renal disorder, but the many extrarenal manifestations of CKD that complicate management.Serum albumin is a strong predictor for adverse outcomes in adults with chronic kidney disease (CKD). Because these conditions are amenable to treatments, recognition of hypoalbuminemia and underlying status may improve patient management, potentially leading to better clinical outcomes.Hypoalbuminemia is known to be an independent predictor of survival and hospitalization in adult patients with end-stage renal disease (ESRD) on dialysis.In children with ESRD, a few studies have focused on mortality or hospitalization as outcomes, showing the association of hypoalbuminemia with high mortality in incident dialysis patients and high hospitalization frequency in prevalent dialysis patients.Further, patients with chronic diseases and hypoalbuminemia lose fat-free mass, considered to be an essential indicator of the undernourished state, despite adequate food intake.Protein energy wasting (PEW) is common in patients with CKD and associated with adverse clinical Outcomes .(PEW) is closely associated with malnutrition and inflammation, where serum albumin is an established surrogate biomarker.
Children with CKD are also at high risk of poor nutrition and chronic inflammation .Malnutrition and inflammation are associated with adverse outcomes such as death or hospitalization.Furthermore, among children with CKD, inadequate nutrition is one of the most common causes of growth failure, resulting in short stature or low body mass index (BMI)which is also associated with death or hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- other causes of hypoalbuminemia such as heart disease, diabetes mellitus , hepatic failure .
- chronic kidney disease without hypoalbuminemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.
Time frame: 2years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 21629229Kalantar-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.
- Background: PubMed 28434208Palmer 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.
- Background: PubMed 8840944Iseki 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.
- Background: PubMed 11849406Wong 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.
- Background: PubMed 21947116Rees 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.
- Background: PubMed 19083024Silverstein 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.
- Background: PubMed 25906893Rees 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azaa Eltayib, Professor contact
Ahmed Elmenshawy study director
Assist university
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdelguad, Resident (01023751005, ataay411@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease. (time frame: 2years). 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 NCT06268314, which also lists 7 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 5 Mar 2024.