EFFICIENCY AND SAFETY OF CLINAVIT PAEDIATRIC AT A WEIGHT DEPENDANT DOSE ADMINISTERED DAILY FOR 5 CONTINUOUS DAYS ON 4 VITAMINS BLOOD LEVEL IN NEONATES AND CHILDREN UP TO 11 YEARS OF AGE RECEIVING PARENTERAL NUTRITION. A PROSPECTIVE, MULTICENTRE, RANDOMISED, COMPARATIVE, DOUBLE BLIND PHASE III STUDY IN THERAPEUTIC USE VERSUS SOLUVIT AND VITALIPID INFANT CARRIED OUT IN PARALLEL GROUPS. EFICACIA Y SEGURIDAD DE CLINAVIT PEDIÁTRICO, A UNA DOSIS DEPENDIENTE DEL PESO, ADMINISTRADO A DIARIO DURANTE 5 DÍAS CONSECUTIVOS, MEDIDAS POR LA CONCENTRACIÓN SANGUÍNEA DE 4 VITAMINAS EN NEONATOS Y NIÑOS DE HASTA 11 AÑOS DE EDAD TRATADOS CON NUTRICIÓN PARENTERAL. ESTUDIO EN FASE III PROSPECTIVO, MULTICÉNTRICO, ALEATORIZADO, COMPARATIVO, ABIERTO Y DE GRUPOS PARALELOS EN USO TERAPÉUTICO FRENTE A SOLUVIT Y VITALIPID INFANT.

• Conditions: o special medical condition but Patient requiring for any underlying pathology at least 5 days of total parenteral nutrition, representing at least 90% of their total energy needs

• Registration Number: EUCTR2004-001569-16-ES
• Lead Sponsor: BAXTER SAS R&D Parenteral Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

·In or out patients of both genders,·
Aged up to 11 years of age at the first visit,·
Patient requiring for any underlying pathology at least 5 days of total parenteral nutrition, representing at least 90% of their total energy needs,·
Patient to be supplemented by intravenous vitamins,·
Patient whose parents or legal representative have freely given their written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Known HIV infection,·
Known pre-existing hypervitaminosis,·
Known hypersensitivity to intravenous vitamins, or any excipients of the preparation,·
Participation in another clinical trial within a month prior to the first visit, ·
Patient with any underlying pathology at risk of foreseeable drop out before the 6th day,·
Patients requiring treatment by anticonvulsants (barbiturics or phenytoin),·
Patients requiring an extra supplementation by products containing vitamins, whatever the route,·
Previous inclusion in this study,·
Parents or legal representative’s potential non-cooperation or unwillingness to comply fully with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified