The purpose of this study is to demonstrate an increase in protein metabolism during treatment with Physioneal 35® (containing lactate 10 mmol/l, calcium 1.75 mmol/l) compared to treatment with Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children and adolescents with end stage renal failure receiving peritoneal dialysis.
* Fat oxidation (13C-enrichment in expiration breath samples for U-C13-algae turnover) * Growth markers (plasma levels of IgF-1, IgF-BP3, leptin) * Biochemical markers of anabolism (plasma levels of total protein, albumin, transferrin) * Serum thyroid function (fT3, fT4, TSH) * Serum lipid status * Serum markers of calcium/phosphate metabolism (PTH, calcium, ionized calcium, phosphate, alkaline phosphatase) * Prevalence of metabolic acidosis/ alkalosis (venous sample), serum lactate * Safety parameters (such as normalized weekly Kt/v, parameters of glucose metabolism, parameters of hepatic function, parameters of calcium-phosphate-metabolism, physical examination incl. standing height, weight, assessment of complications related to peritoneal dialysis as peritonitis, exit infections and inguinal hernia) * Body composition (lean body mass and body fat mass/fluid)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks
Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks
Pediatric Nephrology, Universiy Children's Hospital
Cologne, Germany
Dept. of Pediatric Nephrology, University Hospital Erlangen
Erlangen, Germany
Dept. of Pediatric Nephrology, University of Hannover
Hanover, Germany
Dept. of Nephrology, children´s hospital Memmingen
Memmingen, Germany
To demonstrate an increase in protein metabolism during treatment with Physioneal 35® compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.
Time frame: 16 weeks
To demonstrate a improved Fat oxidation during treatment with Physioneal compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.
Time frame: 16 weeks
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Dept. of Nephrology, University of Rostock
Rostock, Germany