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

ISRCTN ISRCTN11132850
DOI https://doi.org/10.1186/ISRCTN11132850
Secondary identifying numbers 06/178
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

Study designRandomised controlled single-blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNutritional 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) studiedMalnutrition
InterventionSpecific 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 typeOther
Primary outcome measureThe 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 measuresCollected 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 study start date15/11/2007
Completion date15/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment15/11/2007
Date of final enrolment15/05/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

Avenida Marques de Corbera 6, 6d
Madrid
28017
Spain

Sponsor information

Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain)
Research organisation

Hospital Clinico san Carlos
C/ Martin Lagos S/N
Madrid
28040
Spain

Phone +34 91 33 03 64 3
Email krekshi@hotmail.com

Funders

Funder type

Research organisation

Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain) - in cooperation with the Hospital Clinco San Carlos (Spain), Department of Endocrinology and Nutrition

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan