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Completed

NCT Number: NCT02102009

Nutritional Supplementation in Adults With Chronic Respiratory Disease

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.

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Key information

Conditions

Malnutrition Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Other Pulmonary Disease, Chronic Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica San Gabriel

San Miguel, Lima region, 2955, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Complete enteral formula

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.

Other names: Vitafos, Vitafos Adultos, Vitafos Vainilla

Dietary Advise

Other

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

Primary outcomes

  1. Changes in nutritional status

    Time frame: 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.

  2. Changes in pulmonary function

    Time frame: At 3rd month

    Differences in forced expiratory volume measured by spirometry.

Secondary outcomes

  1. Respiratory Infections

    Time frame: At 1st, 2nd, 3rd month

    Differences measured by number of infections and hospital readmission rate.

  2. Muscular Strength

    Time frame: At 3rd month.

    Differences measured by hand-grip strength.

  3. Exercise Tolerance

    Time frame: At 3th month

    Differences measured by six minutes walk test.

  4. Quality of Life of the participants

    Time frame: At hospital discharge or 1st month and 3rd month

    Differences measured by Saint George respiratory questionnaire.

  5. Tolerability of the product

    Time frame: At 1st, 2nd and 3rd months

    Measured by gastrointestinal discomfort and product compliance.

Sponsors and collaborators

Lead sponsor

Laboratorios Ordesa

Industry

Collaborators

  • Peruvian Clinical Research

Registry information

Official study 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..

Acronym: OFOS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2014
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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