NCT02128984

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

March 28, 2014

Last Update Submit

July 17, 2019

Conditions

Cystic FibrosisFailure to ThriveMalnutrition

Keywords

MalnutritionDietary supplementNutritional supplementSymbiotic formulaDHACystic FibrosisFailure to Thrive

Outcome Measures

Primary Outcomes (1)

  • Changes in inflammatory response

    Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.

    At 3rd and 6th months

Secondary Outcomes (4)

  • Changes in nutritional status

    At 3rd and 6th months

  • Changes in microbiota profile

    At 3rd and 6th months

  • Changes in Interleukin levels

    At 6th month

  • Incidence of Infections

    At 1st, 3rd and 6th months

Other Outcomes (1)

  • Tolerability of the formula

    At 1st, 3rd and 6th months

Study Arms (2)

Vitafos Junior

EXPERIMENTAL

Symbiotic Formula with DHA and antioxidants

Dietary Supplement: Symbiotic Formula with DHA and antioxidants

Standard Formula

ACTIVE COMPARATOR

Standard isocaloric and isonitrogenous formula.

Dietary Supplement: Standard Formula

Interventions

Symbiotic Formula with DHA and antioxidantsDIETARY_SUPPLEMENT

6 months intervention.

Also known as: Vitafos Junior
Vitafos Junior
Standard FormulaDIETARY_SUPPLEMENT

6 months intervention.

Standard Formula

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Instituto Nacional de Salud del Niño

Lima, Breña, Peru

Location

Hospital de Henares

Coslada, Madrid, 28822, Spain

Location

Hospital Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

Hospital de Torrecárdenas

Almería, 04009, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Cystic FibrosisFailure to ThriveMalnutrition

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2014

First Posted

May 1, 2014

Study Start

January 1, 2012

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

PE(1)ES(7)