Nutritional Supplementation in Adults With Chronic Respiratory Disease

NCT ID: NCT02102009

Last Updated: 2019-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitafos

Complete enteral formula

Group Type EXPERIMENTAL

Complete enteral formula

Intervention Type DIETARY_SUPPLEMENT

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.

Dietary Advise

Dietary advise according to the hospital routine clinical practice.

Group Type ACTIVE_COMPARATOR

Dietary Advise

Intervention Type OTHER

Patients will receive the usual dietary advise in these patients according hospital clinical practice .

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Dietary Advise

Patients will receive the usual dietary advise in these patients according hospital clinical practice .

Intervention Type OTHER

Other Intervention Names

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Vitafos Vitafos Adultos Vitafos Vainilla

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peruvian Clinical Research

OTHER

Sponsor Role collaborator

Laboratorios Ordesa

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Antonio Camere Torrealva, Doctor

Role: PRINCIPAL_INVESTIGATOR

Clínica San Gabriel - Perú

Locations

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Clínica San Gabriel

San Miguel, Lima region, Peru

Site Status

Countries

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Peru

Other Identifiers

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OFOS-01-012

Identifier Type: -

Identifier Source: org_study_id

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