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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02128984 |
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Date of registration:
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28/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
VITJUNIOR |
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Scientific title:
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Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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109 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02128984 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Peru
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Spain
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Failure to Thrive
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Malnutrition
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Cystic Fibrosis
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Intervention(s)
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Dietary Supplement: Standard Formula
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Dietary Supplement: Symbiotic Formula with DHA and antioxidants
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Primary Outcome(s)
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Changes in inflammatory response
[Time Frame: At 3rd and 6th months]
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Secondary Outcome(s)
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Incidence of Infections
[Time Frame: At 1st, 3rd and 6th months]
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Changes in nutritional status
[Time Frame: At 3rd and 6th months]
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Changes in Interleukin levels
[Time Frame: At 6th month]
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Changes in microbiota profile
[Time Frame: At 3rd and 6th months]
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Secondary ID(s)
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VIT-2572-011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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