Improvement of nutritional state by intradialytical parenteral nutrition in children treated with haemodialysis
| ISRCTN | ISRCTN59440030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59440030 |
| Secondary identifying numbers | HIM/2007/059 |
- Submission date
- 18/06/2010
- Registration date
- 16/07/2010
- Last edited
- 16/07/2010
- 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 Mara Medeiros
Scientific
Scientific
Dr. Marquez 162
Colonia Doctores
Mexico City
06720
Mexico
Study information
| Study design | Prospective randomised active controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Improvement of nutritional state by intradialytical parenteral nutrition in children treated with haemodialysis: A prospective, randomised, controlled, crossover trial |
| Study acronym | IDPN (Comparación de la mejoría nutricional por alimentación enteral vs. parenteral intradialítica en niños en programa de hemodiálisis) |
| Study objectives | Intradialytic parenteral nutrition (IDPN) is an effective intervention to improve the nutritional state of children treated with haemodialysis |
| Ethics approval(s) | The local research ethics committee (Comisión de Etica Hospital Infantil de México Federico Gómez) approved on 29th of February 2008 (ref: HIM/2007/059) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 28/05/2008 |
| Completion date | 28/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key exclusion criteria | 1. Hepatic dysfunction 2. Congenital anomalies in amino acid metabolism 3. Use of immunosuppressive drugs 4. Treatment with growth hormone |
| Date of first enrolment | 28/05/2008 |
| Date of final enrolment | 28/05/2011 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Dr. Marquez 162
Mexico City
06720
Mexico
06720
Mexico
Sponsor information
Baxter Healthcare Corporation (USA)
Industry
Industry
Renal Discoveries
1620 Wauegan Road
McGaw Park, Illinois
60085
United States of America
| Website | http://www.baxter.com/healthcare_professionals/grants_program/renal_discoveries_egp.html |
|---|---|
"ROR" |
https://ror.org/02d6ew870 |
Funders
Funder type
Industry
Baxter Healthcare Corporation (USA) - Renal Discoveries BAXTER Extramural grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
