Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HIM/2007/059
Study information
Scientific title
Improvement of nutritional state by intradialytical parenteral nutrition in children treated with haemodialysis: A prospective, randomised, controlled, crossover trial
Acronym
IDPN (Comparación de la mejoría nutricional por alimentación enteral vs. parenteral intradialítica en niños en programa de hemodiálisis)
Study hypothesis
Intradialytic parenteral nutrition (IDPN) is an effective intervention to improve the nutritional state of children treated with haemodialysis
Ethics approval
The local research ethics committee (Comisión de Etica Hospital Infantil de México Federico Gómez) approved on 29th of February 2008 (ref: HIM/2007/059)
Study design
Prospective randomised active controlled crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Malnutrition/Haemodialysis pediatric patients
Intervention
Malnourished children undergoing haemodialysis treatment (aged 6-17 years) will be included in the study. None will be receiving growth hormone. Each patient will receive a three month course of either Treatment A or Treatment B. For ethical reasons there is no washout period and patients will be switched to another three months of either Treatment A or B in order to complete the other arm of the crossover design.
1. Treatment A: Dietary supplementation providing a third daily calorie intake three times per week.
2. Treatment B. A three months course of intradialytical parenteral nutrition in every haemodialysis session (three times per week). The IDPN will provide a third of the required daily calorie intake, amino acids and lipids, will be adjusted by age and sex.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Improvement in ABN score (anthropometry-bioimpedance analysis-nutrition) at 3 and 6 months
Secondary outcome measures
1. improvement in inflammation biomarkers (IL-6, TNF alpha)
1. Peripheral blood gene expression of IL6, TNF alpha, IFN gamma, 18s-rRNA at baseline, 3 and 6 months
2. Adverse events to nutritional intervention
Overall trial start date
28/05/2008
Overall trial end date
28/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 6-17 years
2. Anthropometry-BIA nutrition (ABN) Score <10.33
3. Functional haemodialysis vascular access
4. Expected time in haemodialysis at least 6 months
5. No evidence of active infection
6. Informed consent/assent properly signed
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Hepatic dysfunction
2. Congenital anomalies in amino acid metabolism
3. Use of immunosuppressive drugs
4. Treatment with growth hormone
Recruitment start date
28/05/2008
Recruitment end date
28/05/2011
Locations
Countries of recruitment
Mexico
Trial participating centre
Dr. Marquez 162
Mexico City
06720
Mexico
Sponsor information
Organisation
Baxter Healthcare Corporation (USA)
Sponsor details
Renal Discoveries
1620 Wauegan Road
McGaw Park
Illinois
60085
United States of America
Sponsor type
Industry
Website
http://www.baxter.com/healthcare_professionals/grants_program/renal_discoveries_egp.html
Funders
Funder type
Industry
Funder name
Baxter Healthcare Corporation (USA) - Renal Discoveries BAXTER Extramural grant
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
Basic results (scientific)
Publication list