Nutritional Supplementation in Adults With Chronic Respiratory Disease (OFOS)
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|ClinicalTrials.gov Identifier: NCT02102009|
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Pulmonary Disease, Chronic Obstructive Other Pulmonary Disease, Chronic Obstructive||Dietary Supplement: Complete enteral formula Other: Dietary Advise||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Nutritional Support With an Complete Formula on Nutritional Status and Respiratory Function in Adult Patients Malnourished or at Risk of Malnutrition and Chronic Respiratory Disease..|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Complete enteral formula
Dietary Supplement: Complete enteral formula
Product: Complete nutritional formula in powder enriched with key nutrients to be administered orally (200 ml of water per 57 g product).
Time of intervention: 3 months.
Active Comparator: Dietary Advise
Dietary advise according to the hospital routine clinical practice.
Other: Dietary Advise
Patients will receive the usual dietary advise in these patients according hospital clinical practice .
- Changes in nutritional status [ Time Frame: At hospital discharge or at 1th month and at 3 months ]Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
- Changes in pulmonary function [ Time Frame: At 3rd month ]Differences in forced expiratory volume measured by spirometry.
- Respiratory Infections [ Time Frame: At 1st, 2nd, 3rd month ]Differences measured by number of infections and hospital readmission rate.
- Muscular Strength [ Time Frame: At 3rd month. ]Differences measured by hand-grip strength.
- Exercise Tolerance [ Time Frame: At 3th month ]Differences measured by six minutes walk test.
- Quality of Life [ Time Frame: At hospital discharge or 1st month and 3rd month ]Differences measured by Saint George respiratory questionnaire.
- Tolerability [ Time Frame: At 1st, 2nd and 3rd months ]Measured by gastrointestinal discomfort and product compliance.
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): NCT02102009
|Clínica San Gabriel|
|San Miguel, Lima, Peru, 2955|
|Principal Investigator:||Marco Antonio Camere Torrealva, Doctor||Clínica San Gabriel - Perú|