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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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20 June 2023 |
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Main ID: |
NCT02959450 |
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Date of registration:
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07/11/2016 |
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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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Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
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Scientific title:
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Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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127 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02959450 |
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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: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Aurora E Serralde-Zúñiga, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Oropharyngeal Dysphagia.
- Patients who have primary caregiver.
- Agreeing to participate in the study.
Exclusion Criteria:
- Critically ill patients.
- Chronic kidney disease with Glomerular Filtration Rate <30 ml / min or in renal
replacement therapy
- Liver failure.
- Cancer with active radiotherapy or chemotherapy treatment.
- Patients who are participating in another study.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Oropharyngeal Dysphagia
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Intervention(s)
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Dietary Supplement: Modified consistency and volume diet
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Primary Outcome(s)
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Adequacy of Oral Intake of Protein
[Time Frame: 12 months]
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Adequacy of Oral Intake of Energy
[Time Frame: 12 months]
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Secondary Outcome(s)
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Swallowing Ability
[Time Frame: 12 months]
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Body Weight
[Time Frame: 12 months]
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BMI
[Time Frame: 12 months]
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Mortality
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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