The Nutritional Effect between ONCE Dialyze compare with diet counseling on malnourished hemodialysis patients
Phase 3
Completed
- Conditions
- dialysis,malnutritionstable patients with HD 3 time/wkserum albumin level <3.8 g/dLdietary protein intake <1 g/kg/daydietary energy intake <25 kcal/kg/dayGet risk of malnutrition from MIS score evaluationONCE dialyze,Hemodialysis,
- Registration Number
- TCTR20200801001
- Lead Sponsor
- Thai Otsuka Pharmaceutical Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
HD patients over 18 years old
stable patients with HD at least 3 months before enrollment
stable patients with HD 3 time/wk
serum albumin level <3.8 g/dL
dietary protein intake <1 g/kg/day
dietary energy intake <25 kcal/kg/day
Get risk of malnutrition from MIS score evaluation
Exclusion Criteria
Chronic liver disease
Chronic inflammatory disease
Swallowing or GI dysfunction
Kt/V > 1.2
Hospitalization
Take medical food within 1 month before enrollment
Allergic to supplement components
Be diaged as fluid overload
Be diaged as canceer within 5 years
Take medicine effected to nutrition status
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method utrition status Day 0, Day 15 ( for prealbumin ) , Day 30 Prealbumin, Albumin , MIS score
- Secondary Outcome Measures
Name Time Method Safety of product Day 0 ,30 Side effect, Quality of life (SF-36)