Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children (VITJUNIOR)

Laboratorios Ordesa

Status: Completed

Conditions: Failure to Thrive; Malnutrition; Cystic Fibrosis

Treatments: Dietary Supplement: Standard Formula; Dietary Supplement: Symbiotic Formula with DHA and antioxidants

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02128984

VIT-2572-011

Details and patient eligibility

About

The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.

Full description

This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.

Enrollment: 109 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
• Age >= 1 year.
• Stable patients
• No antibiotherapy in the last 30 days
• Inform consent signed (parent/legal representative)

Exclusion criteria

• Patients with allergy / intolerance to cow's milk proteins
• Metabolically unstable patient
• Patients with metabolic intolerance to carbohydrates
• Patients with severe disease in the last 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups

Vitafos Junior

Experimental group

Description:

Symbiotic Formula with DHA and antioxidants

Treatment:

Dietary Supplement: Symbiotic Formula with DHA and antioxidants

Standard Formula

Active Comparator group

Description:

Standard isocaloric and isonitrogenous formula.

Treatment:

Dietary Supplement: Standard Formula