Efficacy of oral intra-dialysis supplement in haemodialysis patients with malnutrition

ISRCTN	ISRCTN11132850
DOI	https://doi.org/10.1186/ISRCTN11132850
Protocol serial number	06/178
Sponsor	Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain)
Funder	Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain) - in cooperation with the Hospital Clinco San Carlos (Spain), Department of Endocrinology and Nutrition

Submission date: 06/11/2007
Registration date: 27/11/2007
Last edited: 28/11/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Waeel Ibrahim Alkrekshi
Scientific

Avenida Marques de Corbera 6, 6d
Madrid
28017
Spain

Phone	+34 91 62 78 88 95 0
Email	krekshi@hotmail.com

Study information

Primary study design	Interventional
Study design	Randomised controlled single-blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Nutritional support in the form of oral supplement during the sessions of haemodilaysis improves the nutritional status of the patients, increases the oral food intake, improves the functional situation and quality of life and reduces the morbidity and mortality.
Ethics approval(s)	Ethics approval received from the Ethical Committee of Clinical Investigation of the Hospital Clinico San Carlos on the 24th January 2007 (ref: 1.2/07). Signed by secretary of the committee Dr. M. Garcia Arenillas.
Health condition(s) or problem(s) studied	Malnutrition
Intervention	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 product of Abbott laboratory. Dosage is 236 ml in each session of haemodialysis, providing 472 kcal and 7 g of protein per 100 ml. Duration of intervention: 6 months
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	15/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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)
Key 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
Date of first enrolment	15/11/2007
Date of final enrolment	15/05/2008

Locations

Countries of recruitment

Spain

Study participating centre

Avenida Marques de Corbera 6, 6d

Madrid
28017
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan