OFOS: Nutritional Supplementation in Adults With Chronic Respiratory Disease

Sponsor

Laboratorios Ordesa (Industry)

Overall Status

Completed

CT.gov ID

NCT02102009

Collaborator

Peruvian Clinical Research (Other)

Enrollment

Location

Arms

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition Pulmonary Disease, Chronic Obstructive Other Pulmonary Disease, Chronic Obstructive	Dietary Supplement: Complete enteral formula Other: Dietary Advise	N/A

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 Design

Study Type:

Interventional

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 :

Apr 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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 .

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 .

Outcome Measures

Primary Outcome Measures

Changes in nutritional status [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 [At 3rd month]
Differences in forced expiratory volume measured by spirometry.

Secondary Outcome Measures

Respiratory Infections [At 1st, 2nd, 3rd month]
Differences measured by number of infections and hospital readmission rate.
Muscular Strength [At 3rd month.]
Differences measured by hand-grip strength.
Exercise Tolerance [At 3th month]
Differences measured by six minutes walk test.
Quality of Life of the participants [At hospital discharge or 1st month and 3rd month]
Differences measured by Saint George respiratory questionnaire.
Tolerability of the product [At 1st, 2nd and 3rd months]
Measured by gastrointestinal discomfort and product compliance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.