A STUDY OF SAFETY AND EFFICACY OF NUTRI-JELLY IN END STAGE RENAL DISEASE PATIENTS UNDERGOING HEMODIALYSIS

Phase 1

Completed

• Conditions: End-stage renal failure with hemodialysis; Nutritional status; Renal failure, End-stage; Hemodialysis; Adverse effect

• Registration Number: TCTR20230507001
• Lead Sponsor: Program in Toxicology and Nutrition for Food Safety

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-05
• Study Start: 2023-05-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

being diagnosed with ESRD patients undergoing hemodialysis for at least one year, Outpatients, On regular hemodialysis 3 times a week, HbA1c<9,
Acceptable to eat Nutri-jelly, Age 18-65 years old, Albumin 2.0-4.0 g/dl(>3.5g/dl), k+<6 mg/dl, Protein intake 0.50-0.70 g. per kg body weight: day (1.2g/ kg body weight: day), IBW 50-60 kg

Exclusion Criteria

Medication to control electrolytes, Changing in medicine used, Primary parathyroid diseases, Active infection, Active malignancy, Heart failure, Pregnancy, Allergic to milk, egg, fish, shrimp, Complete nutrition formula intake, Personal use of dietary supplements (Not prescribed /recommended by physicians),
Being unable to make a reliable decision or effective communication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chage in GFR 0,7 Days Blood Chemistry,Chage in BUN 0,7 Days Blood chemistry,Chage in Creatinine 0,7 Days Blood Chemistry,Chage in Alubumin 0,7 Days Blood chemistry,Chage in Potassium 0,7 Days Blood chemistry,Chage in Phosphorus 0,7 Days Blood chemistry,Chage in Sodium 0,7 Days Blood chemistry

Secondary Outcome Measures

Name	Time	Method
Efficacy of hemodialysis 1 month Nurse reported outcome using a nurse note.