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Nutritional Supplementation in Adults With Chronic Respiratory Disease (OFOS)

Primary Purpose

Malnutrition, Pulmonary Disease, Chronic Obstructive, Other Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Complete enteral formula
Dietary Advise
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, Dietary supplement, Nutritional supplement, Complete enteral formula, COPD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Clínica San Gabriel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitafos

Dietary Advise

Arm Description

Complete enteral formula

Dietary advise according to the hospital routine clinical practice.

Outcomes

Primary Outcome Measures

Changes in nutritional status
Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
Changes in pulmonary function
Differences in forced expiratory volume measured by spirometry.

Secondary Outcome Measures

Respiratory Infections
Differences measured by number of infections and hospital readmission rate.
Muscular Strength
Differences measured by hand-grip strength.
Exercise Tolerance
Differences measured by six minutes walk test.
Quality of Life of the participants
Differences measured by Saint George respiratory questionnaire.
Tolerability of the product
Measured by gastrointestinal discomfort and product compliance.

Full Information

First Posted
March 28, 2014
Last Updated
July 17, 2019
Sponsor
Laboratorios Ordesa
Collaborators
Peruvian Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02102009
Brief Title
Nutritional Supplementation in Adults With Chronic Respiratory Disease
Acronym
OFOS
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
Collaborators
Peruvian Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Pulmonary Disease, Chronic Obstructive, Other Pulmonary Disease, Chronic Obstructive
Keywords
Malnutrition, Dietary supplement, Nutritional supplement, Complete enteral formula, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitafos
Arm Type
Experimental
Arm Description
Complete enteral formula
Arm Title
Dietary Advise
Arm Type
Active Comparator
Arm Description
Dietary advise according to the hospital routine clinical practice.
Intervention Type
Dietary Supplement
Intervention Name(s)
Complete enteral formula
Other Intervention Name(s)
Vitafos, Vitafos Adultos, Vitafos Vainilla
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Advise
Intervention Description
Patients will receive the usual dietary advise in these patients according hospital clinical practice .
Primary Outcome Measure Information:
Title
Changes in nutritional status
Description
Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
Time Frame
At hospital discharge or at 1th month and at 3 months
Title
Changes in pulmonary function
Description
Differences in forced expiratory volume measured by spirometry.
Time Frame
At 3rd month
Secondary Outcome Measure Information:
Title
Respiratory Infections
Description
Differences measured by number of infections and hospital readmission rate.
Time Frame
At 1st, 2nd, 3rd month
Title
Muscular Strength
Description
Differences measured by hand-grip strength.
Time Frame
At 3rd month.
Title
Exercise Tolerance
Description
Differences measured by six minutes walk test.
Time Frame
At 3th month
Title
Quality of Life of the participants
Description
Differences measured by Saint George respiratory questionnaire.
Time Frame
At hospital discharge or 1st month and 3rd month
Title
Tolerability of the product
Description
Measured by gastrointestinal discomfort and product compliance.
Time Frame
At 1st, 2nd and 3rd months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Antonio Camere Torrealva, Doctor
Organizational Affiliation
Clínica San Gabriel - Perú
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica San Gabriel
City
San Miguel
State/Province
Lima
ZIP/Postal Code
2955
Country
Peru

12. IPD Sharing Statement

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Nutritional Supplementation in Adults With Chronic Respiratory Disease

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