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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
Sponsor:
Collaborator:
Peruvian Clinical Research
Information provided by (Responsible Party):
Laboratorios Ordesa

Brief Summary:
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.

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

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitafos
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.

Other Names:
  • Vitafos
  • Vitafos Adultos
  • Vitafos Vainilla

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 .




Primary Outcome Measures :
  1. 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.

  2. Changes in pulmonary function [ Time Frame: At 3rd month ]
    Differences in forced expiratory volume measured by spirometry.


Secondary Outcome Measures :
  1. Respiratory Infections [ Time Frame: At 1st, 2nd, 3rd month ]
    Differences measured by number of infections and hospital readmission rate.

  2. Muscular Strength [ Time Frame: At 3rd month. ]
    Differences measured by hand-grip strength.

  3. Exercise Tolerance [ Time Frame: At 3th month ]
    Differences measured by six minutes walk test.

  4. Quality of Life [ Time Frame: At hospital discharge or 1st month and 3rd month ]
    Differences measured by Saint George respiratory questionnaire.

  5. Tolerability [ Time Frame: At 1st, 2nd and 3rd months ]
    Measured by gastrointestinal discomfort and product compliance.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 18 and 80 years.
  • Patient from Clínica San Gabriel or Clínica San Pablo Surco, inpatient or outpatient.
  • Patients with chronic pulmonary disease (including bronchiectasis, tuberculosis specific sequel, fibrothorax, diffuse interstitial lung disease, COPD).
  • Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients ≥ 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last moth; FFMI <15 kg/m2 (women) or <16 kg/m2 (men).
  • Patients who signed informed consent.

Exclusion Criteria:

  • Clinically unstable patients.
  • Patients requiring other nutritional supplements or parenteral nutrition.
  • Patients diagnosed with active pulmonary tuberculosis.
  • Patients with acute respiratory failure.
  • Patients with immunosuppression (including HIV, diabetes or neoplasms).

Information from the National Library of Medicine

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


Locations
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Peru
Clínica San Gabriel
San Miguel, Lima, Peru, 2955
Sponsors and Collaborators
Laboratorios Ordesa
Peruvian Clinical Research
Investigators
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Principal Investigator: Marco Antonio Camere Torrealva, Doctor Clínica San Gabriel - Perú

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Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT02102009     History of Changes
Other Study ID Numbers: OFOS-01-012
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Laboratorios Ordesa:
Malnutrition
Dietary supplement
Nutritional supplement
Complete enteral formula
COPD

Additional relevant MeSH terms:
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Lung Diseases
Malnutrition
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Nutrition Disorders
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive