Contact information
Type
Scientific
Primary contact
Dr Waeel Ibrahim Alkrekshi
ORCID ID
Contact details
Avenida Marques de Corbera 6
6d
Madrid
28017
Spain
+34 91 62 78 88 95 0
krekshi@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06/178
Study information
Scientific title
Acronym
Study hypothesis
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
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.
Study design
Randomised controlled single-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 outcome measures
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
Overall trial start date
15/11/2007
Overall trial end date
15/05/2008
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
15/11/2007
Recruitment end date
15/05/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Avenida Marques de Corbera 6, 6d
Madrid
28017
Spain
Sponsor information
Organisation
Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain)
Sponsor details
Hospital Clinico san Carlos
C/ Martin Lagos S/N
Madrid
28040
Spain
+34 91 33 03 64 3
krekshi@hotmail.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain) - in cooperation with the Hospital Clinco San Carlos (Spain), Department of Endocrinology and Nutrition
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary