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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
Sponsor:
Collaborators:
Quantum Experimental
Peruvian Clinical Research
Information provided by (Responsible Party):
Laboratorios Ordesa

Brief Summary:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Changes in inflammatory response [ Time Frame: At 3rd and 6th months ]
    Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.


Secondary Outcome Measures :
  1. 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.

  2. Changes in microbiota profile [ Time Frame: At 3rd and 6th months ]
    Differences measured by changes in faecal microbiota composition.

  3. Changes in Interleukin levels [ Time Frame: At 6th month ]
    Differences in faecal interleukin levels. Only for cystic fibrosis patients.

  4. Incidence of Infections [ Time Frame: At 1st, 3rd and 6th months ]
    Episodes of infections during the study period


Other Outcome Measures:
  1. Tolerability of the formula [ Time Frame: At 1st, 3rd and 6th months ]
    Tolerability to the formula in both groups



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Peru
Instituto Nacional de Salud del Niño
Lima, Breña, Peru
Spain
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
Sponsors and Collaborators
Laboratorios Ordesa
Quantum Experimental
Peruvian Clinical Research

Additional Information:
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Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT02128984     History of Changes
Other Study ID Numbers: VIT-2572-011
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

Keywords provided by Laboratorios Ordesa:
Malnutrition
Dietary supplement
Nutritional supplement
Symbiotic formula
DHA
Cystic Fibrosis
Failure to Thrive

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Malnutrition
Failure to Thrive
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Nutrition Disorders
Signs and Symptoms
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs