Nutritional Supplementation in Adults With Chronic Respiratory Disease (OFOS)

Laboratorios Ordesa

Status: Completed

Conditions: Other Pulmonary Disease, Chronic Obstructive; Malnutrition; Pulmonary Disease, Chronic Obstructive

Treatments: Other: Dietary Advise; Dietary Supplement: Complete enteral formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02102009

OFOS-01-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Vitafos

Experimental group

Description:

Complete enteral formula

Treatment:

Dietary Supplement: Complete enteral formula

Dietary Advise

Active Comparator group

Description:

Dietary advise according to the hospital routine clinical practice.

Treatment:

Other: Dietary Advise