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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ghada Alsadfy, Prof contact

01111985154

‫gelsedfy@hotmail.com‬

Samaher Fathy, Dr contact

01006268487

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.

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 groups in NCT04177368
Study groupRoleWhat they receive
assess nutrition with regular dialysisThis 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.

  1. 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.

  1. First posted26 Nov 2019
  2. Study start1 Jan 2020 (estimated)
  3. Primary completion1 Jul 2020 (estimated)
  4. Study completion1 Nov 2020 (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
Case-control
Time perspective
Cross-sectional
Enrolment
55 participants (estimated)
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

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.

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