Malnutrition Nutritional, Metabolic, Endocrine Malnutrition
Conditions
Interventions
Specific oral supplement formula for patients on haemodialysis (Nepro) plus dietetic consultation for the case group, versus only dietetic consultation for the control group.
The formula is Nepro, a
Sponsors
Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old 2. Maintained haemodialysis (at least 6 months on dialysis) 3. Malnutrition criteria (Subjective Global Assessment [SGA] grade B or C or Malnutrition Inflammation Score [MIS] score greater than 8) and at least two altered analytical parameters (albumin less than 3.7 g/dl, prealbumin less than 30 g/l, total cholesterol less than 200 mg/dL with C-Reactive Protein [CRP] within normal range)
Exclusion criteria
Exclusion criteria: 1. Lack of signed consent 2. Difficulty in understanding Spanish language 3. Patients diagnosed of cancer except skin cancer 4. Patients went through surgical operation in the last three months 5. Patients with Dementia or Alzheimer disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following data will be collected at the beginning of the study (basal), and at three and six months (final): 1. Serum albumin, measured by blood analysis 2. Prealbumin, measured by blood analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Collected at the beginning of the study (basal), collected at the beginning of the study (basal), and at three and six months (final): 1. Prevalence of malnutrition 2. Anthropometric nutritional parameters 3. Analytical nutritional parameters 4. Body composition (collected at the beginning of the study [basal] and at the sixth month [final] only) 5. Quality of life 6. Functional scale 7. Appetite 8. Oral food intake. Later on this information will be passed through a special program in order to calculate the total caloric intake and food composition (protein, carbohydrates and fat including saturated, mono- and poly-unsaturated fat) 9. Hospital admissions (collected as and when these events happen) 10. Mortality (collected as and when these events happen) 11. Morbidity and mortality rate (collected as and when these events happen) Measurements taken to assess these outcomes will include: 1. Anthropometric measures: dry body weight, Body Mass Index (BMI), Brachial Muscle Circumference (BMC), triceps skin fold 2. Blood tests: Complete Blood Count (CBC), urea prior and post dialysis, creatinine, electrolytes, lipid profile, serum iron, ferritin, vitamin B12, folic acid, Parathyroid Hormone (PTH), calcium, phosphate, vitamin D3, transferrin, albumin, prealbumin, bicarbonate (HCO3) prior and post dialysis, insulin, fasting blood sugar, Homeostasis Model Assessment (HOMA) index, C-Reactive Protein (CRP) 3. Body composition: electrical Bioimpedance Analysis (BIA) monofrequency 4. Nutritional assessment: SGA and MIS 5. Questionnaires: charlson index, karnofsky scales (evaluated by interviewing each patient and by checking his medical history report at the beginning of the study, third month and sixth month), 36-item Short Form health survey (SF-36) and 8-item Council on Nutrition Appetite Questionnaire (CNAQ) 6. Dietary recall (48 hours): day of dialysis and day off will be collected from patients interview | — |
Countries
Spain
Outcome results
None listed