Nutritional Supplementation in Adults With Chronic Respiratory Disease (OFOS)

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..

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Malnutrition; Other Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Dietary supplement: Complete enteral formula; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima
    • San Miguel, Lima, Peru, 2955
      • Clínica San Gabriel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: Peruvian Clinical Research
• Investigators: Principal Investigator: Marco Antonio Camere Torrealva, Doctor, Clínica San Gabriel - Perú

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: COPD; Dietary supplement; Malnutrition; Nutritional supplement; Complete enteral formula
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Malnutrition; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: OFOS-01-012