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 ONCE dialyze,
Conditions
Interventions
Suppplement for dialysis pateints ,supplement competitor in market for dialysis patients ,Patients wiill be councelled about nutrition for HD patients to eat suitable food without dietary supplement
Experimental Dietary Supplement,Active Comparator Dietary Supplement,Active Comparator Behavioral
Group A : ONCE Dialyze,Gruop B : Nepro,Group C : Nutrition councelling
Sponsors
Thai Otsuka Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutrition status Day 0, Day 15 ( for prealbumin ) , Day 30 Prealbumin, Albumin , MIS score | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of product Day 0 ,30 Side effect, Quality of life (SF-36) | — |
Contacts
Public ContactThipvadee Yamchuenponng
Thai otsuka Pharmaceutical Co.,Ltd
Outcome results
None listed