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To study the effect of oral non-protein energy supplement on malnutrition in patients with CKD stage 4 - 5 and peritoneal dialysis

To study the effect of oral non-protein energy supplement on malnutrition in patients with CKD stage 4 - 5 and peritoneal dialysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016536
Enrollment
Unknown
Registered
2018-06-07
Start date
2018-05-24
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Interventions

CKD stage 4:take orally non-protein energy supplement ferreka for 3 months
CKD stage 5:take orally non-protein energy supplement ferreka for 3 months
maintenance peritoneal dialysis:take orally non-protein energy supplement ferreka for 3 months

Sponsors

Department of clinical nutrition, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. CKD4 phase (eGFR<30ml/min.1.73m2), CKD5 phase (eGFR<15ml/min.1.73m2), or maintenance peritoneal dialysis patients (in stable condition, regular dialysis for over 6 months, and the dialysis plan will be unchanged before or after the entry of the group ); 2. Aged 18 to 70 years, regular follow-up outpatients of CKD4-5 or maintenance peritoneal dialysis in chronic kidney disease or peritoneal dialysis center, or hospitalization of CKD4-5 or maintenance peritoneal dialysis patients in nephrology department of Tongji Hospital; 3. malnutrition: a subjective comprehensive nutrition assessment (SGA) was used for nutritional screening and assessment of patients with CKD4-5 and maintenance peritoneal dialysis, with a score of B or C, or less than 18.5 of BMI; 4. voluntarily participated in the study, maintaining stable diet and good compliance during the trial, and signing informed consent in accordance with the regulations.

Exclusion criteria

Exclusion criteria: 1. patients with severe gastrointestinal diseases, such as acute gastrointestinal bleeding, intestinal obstruction or severe digestive malabsorption; 2. patients with high blood glucose and blood lipids (including type 2 diabetes) and those without blood glucose and lipid control; 3. women in pregnancy or lactation; 4. combined with severe primary diseases such as heart, lung, brain and psychosis; 5. patients who are allergic to any component of the formula; 6. a patient that can not metabolize the nutrients of ferreka congenitally; 7. severe liver dysfunction (ALT is 2.5 times higher than normal); 8. patients who have taken part in other clinical trials in half a year.

Design outcomes

Primary

MeasureTime frame
Human body composition measurement (body weight, body mass index, muscle mass, muscle mass, fat mass, fat ratio, visceral fat area, phase angle);Physical examination (waist, hip, upper arm, calf circumference);Physical fitness test (grip strength, repeated chair stands, 4 meters gait speed, stair climb power test);SF-36 Quality of Life Survey;Modified quantitative subjective global assessment(MQSGA);Plasma albumin, prealbumin, total protein;Lymphocyte count, C-reactive protein, total iron binding capacity;Renal function (creatinine, urea nitrogen, bicarbonate, glomerular filtration rate);

Secondary

MeasureTime frame
blood uric acid, parathyroid hormone, electrolytes (potassium, sodium, calcium, phosphorus, magnesium, chlorine);24-hour urine biochemistry, 24 hour peritoneal fluid biochemistry;Triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein;

Countries

China

Contacts

Public ContactYing Yao

Department of clinical nutrition, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

yaoyingkk@126.com+86 13720379867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026