Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04756856
Status:
TERMINATED
Last Update Posted:
2025-05-01
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle-targeted Nutritional Therapy for the Recovery From COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Significant change in the profile of recruitable patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical performance - chair-stand', 'timeFrame': '12 weeks', 'description': 'Change in chair-stand test'}], 'secondaryOutcomes': [{'measure': 'Physical performance - chair-stand', 'timeFrame': '24 weeks', 'description': 'Change in chair-stand test at the end of study'}, {'measure': 'Total body muscle mass', 'timeFrame': '24 weeks', 'description': 'Change in total body muscle mass during the study'}, {'measure': 'Appendicular muscle mass', 'timeFrame': '24 weeks', 'description': 'Change in appendicular muscle mass during the study'}, {'measure': 'Functional status - muscle strength', 'timeFrame': '24 weeks', 'description': 'Change in handgrip strength during the study'}, {'measure': 'Fatigue', 'timeFrame': '24 weeks', 'description': 'Change in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) during the study'}, {'measure': 'Energy intake', 'timeFrame': '24 weeks', 'description': 'Change in energy intake during the study'}, {'measure': 'Self-perceived quality of life', 'timeFrame': '24 weeks', 'description': 'Change in quality of life during the study as assessed by the five-level EuroQol five-dimensional (EQ-5D-5L) descriptive system during the study'}, {'measure': 'Body weight', 'timeFrame': '24 weeks', 'description': 'Change in body weight during the study'}, {'measure': 'Serum levels of 25-hydroxy-vitamin D', 'timeFrame': '24 weeks', 'description': 'Change in 25-hydroxy-vitamin D during the study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '32961041', 'type': 'BACKGROUND', 'citation': 'Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22.'}, {'pmid': '31278117', 'type': 'BACKGROUND', 'citation': 'Barichella M, Cereda E, Pinelli G, Iorio L, Caroli D, Masiero I, Ferri V, Cassani E, Bolliri C, Caronni S, Maggio M, Ortelli P, Ferrazzoli D, Maras A, Riboldazzi G, Frazzitta G, Pezzoli G. Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome. Neurology. 2019 Jul 30;93(5):e485-e496. doi: 10.1212/WNL.0000000000007858. Epub 2019 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'To assess the impact of a muscle-targeted nutritional therapy consisting of nutritional counseling and high-quality whey protein-based oral nutritional supplements enriched with leucine and vitamin D, on the recovery of post-COVID-19 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)\n* Recent discharge from hospital for COVID-19\n* Informed consent\n\nExclusion Criteria:\n\n* Any malignant disease during the last five years\n* Known kidney failure (previous glomerular filtration rate \\<30 ml/min);\n* Known liver failure (Child B or C)\n* Psychiatric disease\n* Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)\n* Indications related to the study product:\n\nMore than 10 µg (400 IU) of daily Vitamin D intake from medical sources. More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.\n\n* Known allergy to milk, milk products or other components of the proposed interventions\n* Indication to or ongoing artificial nutrition support\n* Inclusion in other nutrition intervention trials\n* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements\n* Refusal"}, 'identificationModule': {'nctId': 'NCT04756856', 'acronym': 'RE-COVID', 'briefTitle': 'Muscle-targeted Nutritional Therapy for the Recovery From COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Impact of a Muscle-targeted Nutritional Therapy in the Recovery of Post-discharge COVID19 Patients Suffering From Sarcopenia', 'orgStudyIdInfo': {'id': '20210006520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle-target oral nutritional supplementation', 'description': 'Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, and 800 IU vitamin D', 'interventionNames': ['Other: Muscle-target oral nutritional supplementation']}], 'interventions': [{'name': 'Muscle-target oral nutritional supplementation', 'type': 'OTHER', 'description': 'Patients will receive daily for 12 weeks two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, and 800 IU vitamin D. Patients will be also followed for 12 weeks after the suspension of supplementation.', 'armGroupLabels': ['Muscle-target oral nutritional supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Emanuele Cereda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo'}, {'name': 'Riccardo Caccialanza, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Emanuele Cereda', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}