Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/11/2007
Date assigned
27/11/2007
Last edited
28/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes