Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-31 @ 10:13 PM
Study NCT ID:
NCT06569732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': 'The Malnutrition Inflammation Score is a composite score used to determine protein energy wasting. It consists of 10 questions, each rated on a scale from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating more severe malnutrition and inflammation. A score of 5 or above suggests the presence of protein-energy wasting.'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in skeletal muscle mass at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': 'The skeletal muscle mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass'}, {'measure': 'Changes from baseline in body fat mass at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': 'The body fat mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass'}, {'measure': 'Changes from baseline in energy intake at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': 'The energy intake will be assessed using 24-hour diet recall forms'}, {'measure': 'Changes from baseline in protein intake at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': 'The protein intake will be assessed using 24-hour diet recall forms'}, {'measure': 'Changes from baseline in intradialytic weight change at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': 'The intradialytic weight change will be determined based on difference in post-dialysis and pre-dialysis weight of the next dialysis session'}, {'measure': 'Changes from baseline in serum albumin at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': "Serum albumin will be obtained from the participants' routine blood test"}, {'measure': 'Changes from baseline in serum phosphorus at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': "Serum phosphorus will be obtained from the participants' routine blood test"}, {'measure': 'Changes from baseline in serum potassium at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': "Serum potassium will be obtained from the participants' routine blood test"}, {'measure': 'Changes from baseline in handgrip strength at 3-month and 6-month', 'timeFrame': 'Baseline, 3-month, and 6-month', 'description': 'Handgrip strength will be measured using a digital hand dynamometer'}, {'measure': 'Cost-Effectiveness Ratio', 'timeFrame': '6-month', 'description': 'The cost-effectiveness ratio will be calculated by dividing the cost of oral nutrition supplements (unit in Malaysia ringgit) for 6 months with the change in malnutrition inflammation score from baseline to 6-month (refer primary outcome 1). In this analysis, there is no minimum or maximum values, but a lower value indicates better cost-effectiveness (lower cost with a greater health benefit).'}, {'measure': 'Acceptability of oral nutrition supplements', 'timeFrame': '6-month', 'description': 'A questionnaire will be used to assess product acceptance using a 5-point Likert scale. The scale ranges from 1 to 5, with higher scores indicating greater acceptance of the product. The questionnaire consists of 5 questions, so the total score ranges from a minimum of 5 to a maximum of 25.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'protein-energy wasting', 'kidney failure'], 'conditions': ['Protein-Energy Wasting', 'Kidney Failure', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '34977109', 'type': 'BACKGROUND', 'citation': 'Sahathevan S, Karupaiah T, Khor BH, Sadu Singh BK, Mat Daud ZA, Fiaccadori E, Sabatino A, Chinna K, Abdul Gafor AH, Bavanandan S, Visvanathan R, Yahya R, Wahab Z, Goh BL, Morad Z, Bee BC, Wong HS. Muscle Status Response to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting: A Multi-Center Randomized, Open Label-Controlled Trial. Front Nutr. 2021 Dec 10;8:743324. doi: 10.3389/fnut.2021.743324. eCollection 2021.'}, {'pmid': '33076282', 'type': 'BACKGROUND', 'citation': 'Sahathevan S, Khor BH, Ng HM, Gafor AHA, Mat Daud ZA, Mafra D, Karupaiah T. Understanding Development of Malnutrition in Hemodialysis Patients: A Narrative Review. Nutrients. 2020 Oct 15;12(10):3147. doi: 10.3390/nu12103147.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis. It will also learn about the cost-effectiveness of homemade oral nutrition supplements. The main questions it aims to answer are:\n\n* Does homemade oral nutrition supplements improve the nutritional status of patients on hemodialysis with protein energy wasting?\n* What is the cost-effectiveness of homemade oral nutrition supplements?\n\nResearchers will compare homemade oral nutrition supplements to commercial oral nutrition supplements to see if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis.\n\nParticipants will:\n\n* Take homemade or commercial oral nutrition supplements every day for 6 months\n* Have assessment of nutritional status performed by researchers every three monthly'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* on maintenance HD dialysis treatment (thrice weekly and 4-hour per session) for at least three months\n* age 18 - 70 year old\n* diagnosed with protein energy wasting using the malnutrition inflammation score (≥ 5)\n\nExclusion Criteria:\n\n* a history of poor adherence to HD treatment (frequently miss the HD treatment for more than one session every month)\n* a history of frequent hospitalization (more than once in the past one month)\n* on regular oral nutrition supplements\n* diagnosed with malignancy\n* pregnant or lactating women\n* allergic to study products such as soy milk or milk'}, 'identificationModule': {'nctId': 'NCT06569732', 'acronym': 'HOMES-HD', 'briefTitle': 'Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Malaysia Sabah'}, 'officialTitle': 'Clinical Efficacy, Feasibility, and Cost-effectiveness of Homemade Oral Nutrition Supplements on Patients on Hemodialysis With Protein-energy Wasting: a Parallel, Open-labeled, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LPS2409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homemade oral nutrition supplements', 'description': 'Homemade oral nutrition supplements, 200 ml/day', 'interventionNames': ['Other: Homemade oral nutrition supplements']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial oral nutrition supplements', 'description': 'Commercial oral nutrition supplements, 200 ml/day', 'interventionNames': ['Other: Commercial oral nutrition supplements']}], 'interventions': [{'name': 'Homemade oral nutrition supplements', 'type': 'OTHER', 'description': 'The homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices', 'armGroupLabels': ['Homemade oral nutrition supplements']}, {'name': 'Commercial oral nutrition supplements', 'type': 'OTHER', 'description': 'The commercial oral nutrition supplement is kidney-specific oral nutrition supplement that is high in energy and protein, but low in electrolytes and fluid', 'armGroupLabels': ['Commercial oral nutrition supplements']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ban Hock Khor, PhD', 'role': 'CONTACT', 'email': 'khorbanhock@ums.edu.my', 'phone': '+6088320000', 'phoneExt': '104475'}], 'overallOfficials': [{'name': 'Ban Hock Khor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Malaysia Sabah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Malaysia Sabah', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Kidney Foundation Malaysia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Khor Ban Hock', 'investigatorAffiliation': 'Universiti Malaysia Sabah'}}}}