Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/06/2010
Date assigned
16/07/2010
Last edited
16/07/2010
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 Mara Medeiros

ORCID ID

Contact details

Dr. Marquez 162
Colonia Doctores
Mexico City
06720
Mexico

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes