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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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19 February 2015 |
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Main ID: |
NCT01971112 |
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Date of registration:
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10/10/2013 |
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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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Nutritional Intervention and Respiratory Infections in Older Subjects
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Scientific title:
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Effect of Supplementation With Multivitamins and Minerals on the Incidence of Respiratory Infections in Older People in Ecuador: a Randomised Controlled Trial. |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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320 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01971112 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Ecuador
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Contacts
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Name:
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Fernando E Sempertegui, MD |
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Address:
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Telephone:
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593 2 2557673 |
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Email:
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fersempert@biociencias-ceb.org |
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Affiliation:
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Name:
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Fernando E Sempertegui, MD |
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Address:
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Telephone:
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593 2 2557673 |
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Email:
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fersempert@biociencias-ceb.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =65 years
- Mental competence
- Written informed consent
Exclusion Criteria:
- Cancer
- Tuberculosis
- Immunosuppressive therapeutics.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lower Respiratory Tract Infections
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Upper Respiratory Infections
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Intervention(s)
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Dietary Supplement: Multivitamins and minerals
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Primary Outcome(s)
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Incidence of respiratory infections (upper plus lower)
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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CRP blood concentration
[Time Frame: 52 weeks]
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Cathelicidin concentration in supernatants of cultured respiratory mucosa cells
[Time Frame: 52 weeks]
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Mean score of DTH response to Trichophyton and tetanus toxoid
[Time Frame: 52 weeks]
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Secondary ID(s)
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378 DGIP-I
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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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