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

July 17, 2019 updated by: Laboratorios Ordesa
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
    • Breña
      • Lima, Breña, Peru
        • Instituto Nacional de Salud del Nino
  • Spain
      • Almería, Spain, 04009
        • Hospital de Torrecardenas
      • Cádiz, Spain, 11009
        • Hospital Puerta del Mar
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Sevilla, Spain, 41009
        • Hospital Virgen Macarena
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Madrid
      • Coslada, Madrid, Spain, 28822
        • Hospital de Henares
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Hospital Universitario Santa Lucía

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitafos Junior
Symbiotic Formula with DHA and antioxidants
Dietary supplement: Symbiotic Formula with DHA and antioxidants
6 months intervention.
Other Names:
  • Vitafos Junior
Active Comparator: Standard Formula
Standard isocaloric and isonitrogenous formula.
Dietary supplement: Standard Formula
6 months intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in inflammatory response
Time Frame: At 3rd and 6th months
Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
At 3rd and 6th months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 3rd and 6th months
Changes in microbiota profile
Time Frame: At 3rd and 6th months
Differences measured by changes in faecal microbiota composition.
At 3rd and 6th months
Changes in Interleukin levels
Time Frame: At 6th month
Differences in faecal interleukin levels. Only for cystic fibrosis patients.
At 6th month
Incidence of Infections
Time Frame: At 1st, 3rd and 6th months
Episodes of infections during the study period
At 1st, 3rd and 6th months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of the formula
Time Frame: At 1st, 3rd and 6th months
Tolerability to the formula in both groups
At 1st, 3rd and 6th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Ordesa

Collaborators

Peruvian Clinical Research
Quantum Experimental

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIT-2572-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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