Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children (VITJUNIOR)
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|ClinicalTrials.gov Identifier: NCT02128984|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Failure to Thrive Malnutrition||Dietary Supplement: Symbiotic Formula with DHA and antioxidants Dietary Supplement: Standard Formula||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Vitafos Junior
Symbiotic Formula with DHA and antioxidants
Dietary Supplement: Symbiotic Formula with DHA and antioxidants
6 months intervention.
Other Name: Vitafos Junior
Active Comparator: Standard Formula
Standard isocaloric and isonitrogenous formula.
Dietary Supplement: Standard Formula
6 months intervention.
- Changes in inflammatory response [ Time Frame: At 3rd and 6th months ]Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
- Changes in nutritional status [ Time Frame: At 3rd and 6th months ]Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass.
- Changes in microbiota profile [ Time Frame: At 3rd and 6th months ]Differences measured by changes in faecal microbiota composition.
- Changes in Interleukin levels [ Time Frame: At 6th month ]Differences in faecal interleukin levels. Only for cystic fibrosis patients.
- Incidence of Infections [ Time Frame: At 1st, 3rd and 6th months ]Episodes of infections during the study period
- Tolerability of the formula [ Time Frame: At 1st, 3rd and 6th months ]Tolerability to the formula in both groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128984
|Instituto Nacional de Salud del Niño|
|Lima, Breña, Peru|
|Hospital de Henares|
|Coslada, Madrid, Spain, 28822|
|Hospital Universitario Santa Lucía|
|Cartagena, Murcia, Spain, 30202|
|Hospital de Torrecárdenas|
|Almería, Spain, 04009|
|Hospital Puerta del Mar|
|Cádiz, Spain, 11009|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Virgen Macarena|
|Sevilla, Spain, 41009|
|Hospital Universitario Miguel Servet|
|Zaragoza, Spain, 50009|