Efficacy of oral intra-dialysis supplement in haemodialysis patients with malnutrition
ISRCTN | ISRCTN11132850 |
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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
Scientific
Avenida Marques de Corbera 6, 6d
Madrid
28017
Spain
Phone | +34 91 62 78 88 95 0 |
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krekshi@hotmail.com |
Study information
Study design | Randomised controlled single-blinded trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 15/11/2007 |
Completion date | 15/05/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
28017
Spain
Sponsor information
Foundation of Metabolic Studies (Fundacion de estudios metabolicos) (Spain)
Research organisation
Research organisation
Hospital Clinico san Carlos
C/ Martin Lagos S/N
Madrid
28040
Spain
Phone | +34 91 33 03 64 3 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |