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| Name | Class |
|---|---|
| Peruvian Clinical Research | OTHER |
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The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.
This is a unicenter, controlled, randomized, prospective, parallel-group, open-label study to evaluate the effect of a nutritional formula on nutritional status, pulmonary function and quality of life. Adult patients will be randomized to receive the nutritional formula or to follow the standard hospital' dietetic recommendations during 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitafos | Experimental | Complete enteral formula |
|
| Dietary Advise | Active Comparator | Dietary advise according to the hospital routine clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete enteral formula | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in nutritional status | Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures. | At hospital discharge or at 1th month and at 3 months |
| Changes in pulmonary function | Differences in forced expiratory volume measured by spirometry. | At 3rd month |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Infections | Differences measured by number of infections and hospital readmission rate. | At 1st, 2nd, 3rd month |
| Muscular Strength | Differences measured by hand-grip strength. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Antonio Camere Torrealva, Doctor | Clínica San Gabriel - Perú | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica San Gabriel | San Miguel | Lima region | 2955 | Peru |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Dietary Advise | Other | Patients will receive the usual dietary advise in these patients according hospital clinical practice . |
|
| At 3rd month. |
| Exercise Tolerance | Differences measured by six minutes walk test. | At 3th month |
| Quality of Life of the participants | Differences measured by Saint George respiratory questionnaire. | At hospital discharge or 1st month and 3rd month |
| Tolerability of the product | Measured by gastrointestinal discomfort and product compliance. | At 1st, 2nd and 3rd months |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |