Clinical trial NCT02102009: Nutritional Supplementation in Adults With Chronic Respiratory Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Pulmonary Disease, Chronic Obstructive
Other Pulmonary Disease, Chronic Obstructive
Keywords: Malnutrition
Dietary supplement
Nutritional supplement
Complete enteral formula
COPD
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Peruvian Clinical Research
First posted: 2014-04-02
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Changes in nutritional status
timeFrame: At hospital discharge or at 1th month and at 3 months
measure: Changes in pulmonary function
timeFrame: At 3rd month
Secondary outcomes:
measure: Respiratory Infections
timeFrame: At 1st, 2nd, 3rd month
measure: Muscular Strength
timeFrame: At 3rd month.
measure: Exercise Tolerance
timeFrame: At 3th month
measure: Quality of Life of the participants
timeFrame: At hospital discharge or 1st month and 3rd month
measure: Tolerability of the product
timeFrame: At 1st, 2nd and 3rd months
Other outcomes:
Locations:
city: San Miguel
country: Peru
facility: Clínica San Gabriel
state: Lima
Study officials:
affiliation: Clínica San Gabriel - Perú
name: Marco Antonio Camere Torrealva, Doctor
role: PRINCIPAL_INVESTIGATOR
References: