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Improvement of nutritional state by intradialytical parenteral nutrition in children treated with haemodialysis

Improvement of nutritional state by intradialytical parenteral nutrition in children treated with haemodialysis: A prospective, randomised, controlled, crossover trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59440030
Enrollment
20
Registered
2010-07-16
Start date
2008-05-28
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition/Haemodialysis pediatric patients Nutritional, Metabolic, Endocrine

Interventions

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 eithe

Sponsors

Baxter Healthcare Corporation (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Hepatic dysfunction 2. Congenital anomalies in amino acid metabolism 3. Use of immunosuppressive drugs 4. Treatment with growth hormone

Design outcomes

Primary

MeasureTime frame
Improvement in ABN score (anthropometry-bioimpedance analysis-nutrition) at 3 and 6 months

Secondary

MeasureTime frame
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

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026