Skip to main content
OpenTrials
Completed

NCT Number: NCT04365816

NutriCovid30 : Nutritional Evaluation for Covid-19 Infection at D30

Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marie-France VAILLANT

Grenoble, 38043, France

About this study

The recent Covid-19 outbreak has brought USA, European, British and French nutrition learned societies to publish recommendations for the nutritional management of patients infected with the SARS-CoV-2. They reminded that there is a risk of malnutrition for that population.

The emergency and rapid evolution in the situation have led to severe cases of anosmia, ageusia, diarrhea, odynophagia, anorexia etc.. Some of the first patients cured from Covid-19 have lost up to 10 kgs.

To this day, there is no available information regarding either nutritional characteristics or nutritional interventions (enteral or parenteral nutrition, oral nutritional supplements, dietary supplementations) for Covid-19 patients.

The objective of this study is to describe nutritional consequences of the Covid-19 infection for adults, 30 days after their discharge from hospital, as well as the nutritional care they received.

Type and proportion of chronic diseases will be assessed in this trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 30 days or more after discharge from hospital for Covid-19
  • Patient received information about the trial and gave his/her consent
  • Patient capable of answering the phone (alone or with some help)

Exclusion criteria

  • Patient diseased
  • impossibility to collect information from the patient or one of his/her relatives
  • Patient protected by the French Public Health Code (art. L1121-5 à L1121-8)

Treatment and study plan

interview

Other

A survey was created, aiming to collect information about prior history of chronic disease, the Self-Evaluation of Food Intake, dysregulations (anosmia, ageusia...), anthropometric data, food data during and after hospitalisation, healthcare consumption since the discharge from hospital

Primary outcomes

  1. Evaluation of food intake at 1 month after discharge from hospital for COVID

    Time frame: one month after hospital discharge

    Self assessment on the SEFI (Self-Evaluation of Food Intake) scale at one month after hospital discharge: 0 corresponds to the worsen score (no ingesta) and 10 corresponds to the best (same ingesta than before the disease)

Secondary outcomes

  1. Weight variation during the infection

    Time frame: one month after hospital discharge

    Self-reported weight in kilograms, or in the absence of self-reported variations before the disease, during hospitalisation, at hospital discharge, one month after hospital discharge

  2. Clinical signs limiting food intake

    Time frame: one month after hospital discharge

    Effect of these factors (anorexia, dysgeusia, Ear Nose and Throat pain, swallowing disorders, intestinal transit disorders...) on SEFI and weight

  3. Factors limiting food intake

    Time frame: one month after hospital discharge

    Effect of these factors (supply difficulties, disease-related food disgust, limiting food habits or prior diet, hydration difficulties, need for help) on SEFI and weight

  4. Implemented nutritional strategy

    Time frame: one month after hospital discharge

    Effect of nutritional strategy and interventions that were implemented (nutritional advice, adapted meals, oral nutritional supplementation, enteral and parenteral nutrition during hospitalisation and one month after hospital discharge) on SEFI and weight

  5. Pre-existing chronic disorders

    Time frame: one month after hospital discharge

    Effect of pre-existing chronic disorders (pulmonary, chronic inflammatory bowel disease, cardio-vascular disease, diabetes, obesity, cognitive disorders, immunodepression, cancer, inflammatory joint disorder) on SEFI and weight

  6. Covid-19 repercussions

    Time frame: one month after hospital discharge

    Quantifying unscheduled consultations or hospitalisations in the month following discharge from hospital

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • University Grenoble Alps

Registry information

Official study title

Evaluation of the Repercussions of the Coronavirus (Covid 19) Infection on Nutritional Health Status and Nutritional Care : an Observational French Cohort Study One Month After Their Discharge From Hospital

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Jul 28, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.