NCT02102009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

March 28, 2014

Last Update Submit

July 17, 2019

Conditions

MalnutritionPulmonary Disease, Chronic ObstructiveOther Pulmonary Disease, Chronic Obstructive

Keywords

MalnutritionDietary supplementNutritional supplementComplete enteral formulaCOPD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Respiratory Infections

    At 1st, 2nd, 3rd month

  • Muscular Strength

    At 3rd month.

  • Exercise Tolerance

    At 3th month

  • Quality of Life of the participants

    At hospital discharge or 1st month and 3rd month

  • Tolerability of the product

    At 1st, 2nd and 3rd months

Study Arms (2)

Vitafos

EXPERIMENTAL

Complete enteral formula

Dietary Supplement: Complete enteral formula

Dietary Advise

ACTIVE COMPARATOR

Dietary advise according to the hospital routine clinical practice.

Other: Dietary Advise

Interventions

Complete enteral formulaDIETARY_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.

Also known as: Vitafos, Vitafos Adultos, Vitafos Vainilla
Vitafos
Dietary AdviseOTHER

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

Dietary Advise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica San Gabriel

San Miguel, Lima region, 2955, Peru

Location

MeSH Terms

Conditions

MalnutritionPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marco Antonio Camere Torrealva, Doctor

    Clínica San Gabriel - Perú

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 2, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

PE(1)