Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support
NCT ID: NCT05579028
Last Updated: 2022-10-13
Study Results
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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COMPLETED
185 participants
OBSERVATIONAL
2020-06-01
2020-12-01
Brief Summary
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* if additional nutrition support has an effect on recovery of physical health in patients with COVID-19;
* to examine the effect of additional nutrition support on quality of life of patients with COVID-19;
* to examine the effect of the additional nutrition support on hospitalization period of patients with COVID-19.
Participants were split into two groups. One group had the common hospital diet, another group in addition to the common diet was given with NutriDrink® 200 ml X 2 daily. During the observation period participants were asked to measure hand strength measured by hand grip tester and fill out the quality of life standard questionnaire SF-36. In addition, several routine blood tests were performed.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study
Patients of the group received supplemental nutritional support with Nutridrink ONS 200 ml, 2 bottles (400 ml) daily for 28 days from the date of inclusion. In a hospital setting, additional nutritional support will be added to the patient's standard hospital diet. After being discharged from the hospital, the patient will receive at his disposal the required amount of Nutridrink ONS 200 ml in amount of 400 ml per day and will take it in addition to his usual and habitual diet. The Nutridrink ONS 200 ml is recommended to be taken between main meals.
Nutridrink ONS 200 ml
Nutridrink is a high-protein, high-calorie formula for the specialized nutrition of patients with or at risk of malnutrition. The product can be used as an additional or sole source of nutrition
Control
Patients of the group received a standard hospital diet, and upon discharge from the hospital - their usual habitual diet.
No interventions assigned to this group
Interventions
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Nutridrink ONS 200 ml
Nutridrink is a high-protein, high-calorie formula for the specialized nutrition of patients with or at risk of malnutrition. The product can be used as an additional or sole source of nutrition
Eligibility Criteria
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Inclusion Criteria
* Need in respiratory support (oxygen insufflation, non-invasive lung ventilation, artificial lung ventilation, as well in a prone position);
* Ability to take food spontaneously in the amount of 60% and more of energy and protein needs (possibility of spontaneous food intake will be determined with the three-swallow test; consumed food will be controlled with the "quarter of a plate" method);
* The informed consent is signed by a patient for the study enrollment and processing of personal data.
Exclusion Criteria
* Renal failure;
* Hepatic failure;
* Systemic disease;
* Active cancer;
* Poor survival prognosis.
* Aggravation of a patient's condition requiring his transfer to enteral feeding and/or parenteral nutrition;
* Occurrence of complications requiring surgical interventions;
* Patient's transfer for treatment to another inpatient unit;
* Complications induced by the product for additional nutrition support (diarrhea, nausea, vomiting);
* Withdrawal of the informed consent for the study enrollment and processing of personal data.
18 Years
69 Years
ALL
No
Sponsors
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Danone Nutricia
INDUSTRY
Enrollme.ru, LLC
NETWORK
Responsible Party
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Principal Investigators
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Mikhail A Getman, Dr
Role: STUDY_DIRECTOR
Enrollme.ru
Locations
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City clinical hospital # 4
Moscow, , Russia
Pirogov Medical university
Moscow, , Russia
City clinical hospital # 11
Omsk, , Russia
City clinical hospital by Saint George the Great Martyr
Saint Petersburg, , Russia
Pokrovskaya hospital
Saint Petersburg, , Russia
Central city clinical hospital # 24
Yekaterinburg, , Russia
Countries
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Other Identifiers
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RECOVID
Identifier Type: -
Identifier Source: org_study_id
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