Assessment of Nutrition in ESRDNCT04177368
Nutritional Assessment of Children With ESRD on Dialysis
An observational study of Assessment of Nutrition in ESRD, run by Assiut University.
Trial summary
Normal growth can be divided into four important phases: prenatal, infantile, childhood and pubertal. Nutrition is important at all phases of growth, but particularly so during the infantile phase because the rate of growth is higher than at any other time of life and is less dependent on growth hormone than during… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Assessment of Nutrition in ESRD
- What is being tested?
- Theragran 60ml
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Nov 2020
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: assess nutrition with regular dialysis This study aims to assess the growth and the nutritional status in children with end-stage kidney disease on regular hemodialysis to define the degree of malnutrition , predict and quantify the risk for complications deriving from impaired nutritional status .Giving them theragran 60ml ,twice daily for 3 month.
Who may be able to join
- Age : 5-15 Years
- Sex : Male \& Female
- Diagnosed as ESRD and on regular hemodialysis.
- Estimated glomerular filtration rate (eGFR): greater than or equal to 5 mL/min and less than or equal to 15 mL/min.
- Clinically stable.
Who cannot join
- • Infants \& adults
- Not expected to initiate dialysis
- Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min.
- Clinically unstable
Trial locations and contacts
No sites are listed yet.
Samaher Fathy, Dr contact
About this study
Official title: Nutritional Assessment of Children With End Stage Renel Disease(ESRD) on Regular Hemodialysis
Normal growth can be divided into four important phases: prenatal, infantile, childhood and pubertal. Nutrition is important at all phases of growth, but particularly so during the infantile phase because the rate of growth is higher than at any other time of life and is less dependent on growth hormone than during other phases. During the childhood phase, growth becomes more dependent on the GH/insulin-like growth factor-1 axis; growth rate decelerates continuously until the pubertal phase. The pubertal phase results from the coordination of GH and sex steroid production. Together they have an anabolic effect on muscle mass, bone mineralization and body proportions. It is another phase of rapid growth so that nutrition can again modify the genetic growth potential.
Read the detailed description
Achieving an optimal nutritional status is essential for managing paediatric chronic kidney disease, and dietary guidance is frequently provided in clinical practice to achieve a metabolic balance, which is vital for normal growth. Guidelines addressing optimal macro- and micronutrient intake for children with CKD are available, with intake of sodium, potassium, phosphorus, protein, and total calories being common targets of nutritional monitoring.
Normal nutrition can be defined as maintenance of normal growth and body composition. Although it is agreed that nutritional assessment is important in chronic renal failure, there is no single or easy definition or measure of inadequate nutritional status: measurement of nutritional parameters are complicated in CRF because of salt and water imbalances and the potential inappropriateness of using age matched controls in a population that is short and may be delayed in puberty; it has been suggested that it is more appropriate, therefore, to express measures relative to height age and/or pubertal stage.
Malnutrition is common in hem dialysis patients and is a powerful predictor of morbidity and mortality. Although much progress has been made in recent years in identifying the causes and pathogenesis of malnutrition in hemodialysis patients, as well as recognizing the link between malnutrition and morbidity and mortality, no consensus has been reached concerning its management. Along with such conventional interventions as nutritional counseling, oral nutritional supplements, and dialectic parental nutrition, novel preventive and therapeutic strategies have been tested, such as appetite stimulants, growth hormone, androgenic anabolic steroids, and anti-inflammatory drugs, with contradictory and non conclusive results. Malnutrition still remains a great challenge for nephrologists in the third millennium.
Growth failure is almost inextricably linked with chronic kidney disease and end-stage renal disease.Growth failure in CKD has been associated with both morbidly and mortality .Growth failure in the setting of kidney disease is multi factorial and is related to poor nutritional status as well as co morbidities ,such as anemia, bone and mineral disorders, and alterations in hormonal responses, as well as to aspects of treatment such as steroid exposure. Initial reports of renal dwarfism date back to the turn of the twentieth century. Despite advances in conservative treatment and renal replacement therapies, 30-60% of patients with ESRD are short at adulthood.
Hypoalbuminemia is the most powerful predictor of mortality in end-stage renal disease. Since protein-calorie malnutrition can decrease albumin synthesis it is assumed that hypoalbu minemia results principally from malnutrition in these patients, but albumin synthesis may also be decreased as part of the acute-phase response, and hypoalbuminemia can also result from redistribution of albumin pools or from albumin losses.Serum albumin has been identified as a surrogate marker for nutritional status and morbidity / mortality in patients with end-stage renal failure. Although serum albumin may be a reflection of nutrition, low levels may be due to haemodilution, nephrotic syndrome or chronic infection / inflammation.
The most commonly used assessment of nutrition is height and weight, along with head circumference in younger children, plotted on percentile charts. Another way of expressing the relative weight and height is the body mass index, which is important because extremes are associated with increased morbidity and mortality. Skin fold thickness is a measure of subcutaneous fat and mid-arm circumference is a reflection of muscle mass and may therefore be more useful in determining body composition than the calculation of BMI alone.
- Conditions
- Assessment of Nutrition in ESRD
- Being tested
- Theragran 60ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theragran 60mlDietary supplement
history,examination and biochemical values
| Study group | Role | What they receive |
|---|---|---|
| assess nutrition with regular dialysis | This study aims to assess the growth and the nutritional status in children with end-stage kidney disease on regular hemodialysis to define the degree of malnutrition , predict and quantify the risk for complications deriving from impaired nutritional status .Giving them theragran 60ml ,twice daily for 3 month. Receives: Dietary Supplement: Theragran 60ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of malnutrition in children on regular dialysis
malnutrion can be preventable by good nutrition assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Nutrition in ESRDStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shimaa kamel ahmed, Assiut University
- Investigators
- Shimaa Kamel Ahmed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177368
- Sponsor's protocol ID
- NACWESRD
- Status last verified
- Nov 2019
- First submitted
- 22 Sep 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No Plan till this time
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment of Children With End Stage Renel Disease(ESRD) on Regular Hemodialysis
- ClinicalTrials.gov ID
- NCT04177368
- Acronym / sponsor ID
- NACWESRD
- Conditions
- Assessment of Nutrition in ESRD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 26 Nov 2019 (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.
Normal growth can be divided into four important phases: prenatal, infantile, childhood and pubertal. Nutrition is important at all phases of growth, but particularly so during the infantile phase because the rate of growth is higher than at any other time of life and is less dependent on growth hormone than during other phases. During the childhood phase, growth becomes more dependent on the GH/insulin-like growth factor-1 axis; growth rate decelerates continuously until the pubertal phase. The pubertal phase results from the coordination of GH and sex steroid production. Together they have an anabolic effect on muscle mass, bone mineralization and body proportions. It is another phase of rapid growth so that nutrition can again modify the genetic growth potential.
Detailed description
Achieving an optimal nutritional status is essential for managing paediatric chronic kidney disease, and dietary guidance is frequently provided in clinical practice to achieve a metabolic balance, which is vital for normal growth. Guidelines addressing optimal macro- and micronutrient intake for children with CKD are available, with intake of sodium, potassium, phosphorus, protein, and total calories being common targets of nutritional monitoring.
Normal nutrition can be defined as maintenance of normal growth and body composition. Although it is agreed that nutritional assessment is important in chronic renal failure, there is no single or easy definition or measure of inadequate nutritional status: measurement of nutritional parameters are complicated in CRF because of salt and water imbalances and the potential inappropriateness of using age matched controls in a population that is short and may be delayed in puberty; it has been suggested that it is more appropriate, therefore, to express measures relative to height age and/or pubertal stage.
Malnutrition is common in hem dialysis patients and is a powerful predictor of morbidity and mortality. Although much progress has been made in recent years in identifying the causes and pathogenesis of malnutrition in hemodialysis patients, as well as recognizing the link between malnutrition and morbidity and mortality, no consensus has been reached concerning its management. Along with such conventional interventions as nutritional counseling, oral nutritional supplements, and dialectic parental nutrition, novel preventive and therapeutic strategies have been tested, such as appetite stimulants, growth hormone, androgenic anabolic steroids, and anti-inflammatory drugs, with contradictory and non conclusive results. Malnutrition still remains a great challenge for nephrologists in the third millennium.
Growth failure is almost inextricably linked with chronic kidney disease and end-stage renal disease.Growth failure in CKD has been associated with both morbidly and mortality .Growth failure in the setting of kidney disease is multi factorial and is related to poor nutritional status as well as co morbidities ,such as anemia, bone and mineral disorders, and alterations in hormonal responses, as well as to aspects of treatment such as steroid exposure. Initial reports of renal dwarfism date back to the turn of the twentieth century. Despite advances in conservative treatment and renal replacement therapies, 30-60% of patients with ESRD are short at adulthood.
Hypoalbuminemia is the most powerful predictor of mortality in end-stage renal disease. Since protein-calorie malnutrition can decrease albumin synthesis it is assumed that hypoalbu minemia results principally from malnutrition in these patients, but albumin synthesis may also be decreased as part of the acute-phase response, and hypoalbuminemia can also result from redistribution of albumin pools or from albumin losses.Serum albumin has been identified as a surrogate marker for nutritional status and morbidity / mortality in patients with end-stage renal failure. Although serum albumin may be a reflection of nutrition, low levels may be due to haemodilution, nephrotic syndrome or chronic infection / inflammation.
The most commonly used assessment of nutrition is height and weight, along with head circumference in younger children, plotted on percentile charts. Another way of expressing the relative weight and height is the body mass index, which is important because extremes are associated with increased morbidity and mortality. Skin fold thickness is a measure of subcutaneous fat and mid-arm circumference is a reflection of muscle mass and may therefore be more useful in determining body composition than the calculation of BMI alone.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assess nutrition with regular dialysis | – | Dietary Supplement: Theragran 60mlThis study aims to assess the growth and the nutritional status in children with end-stage kidney disease on regular hemodialysis to define the degree of malnutrition , predict and quantify the risk for complications deriving from impaired nutritional status .Giving them theragran 60ml ,twice daily for 3 month. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- assess nutrition with regular dialysis This study aims to assess the growth and the nutritional status in children with end-stage kidney disease on regular hemodialysis to define the degree of malnutrition , predict and quantify the risk for complications deriving from impaired nutritional status .Giving them theragran 60ml ,twice daily for 3 month.
Key inclusion criteria (5 listed)
- Age : 5-15 Years
- Sex : Male \& Female
- Diagnosed as ESRD and on regular hemodialysis.
- Estimated glomerular filtration rate (eGFR): greater than or equal to 5 mL/min and less than or equal to 15 mL/min.
- Clinically stable.
Key exclusion criteria (4 listed)
- • Infants \& adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theragran 60mlhistory,examination and biochemical values | Dietary supplement | assess nutrition with regular dialysis |
Primary outcome
prevention of malnutrition in children on regular dialysis
Time frame: 1 year
malnutrion can be preventable by good nutrition assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: Undecided. No Plan till this time
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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.
Samaher Fathy, Dr contact
Shimaa Kamel Ahmed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of Nutrition in ESRD, 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 5 inclusion and 4 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 26 Nov 2019. 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 Ghada Alsadfy, Prof (01111985154, gelsedfy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of malnutrition in children on regular dialysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2019.