Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-02-25 @ 3:35 AM
Study NCT ID:
NCT01874106
Status:
COMPLETED
Last Update Posted:
2014-01-08
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum Albumin', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Subjective Global Assessment (SGA) score', 'timeFrame': '10 weeks'}, {'measure': 'Change in Malnutrition-inflammation score(MIS)', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum C-Reactive Protein(CRP)', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum malondialdehyde(MDA)', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum Interleukin-6(IL-6)', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum total antioxidant capacity(TAC)', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum ferritin', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum total iron binding capacity(TIBC)', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum urea nitrogen', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum creatinine', 'timeFrame': '10 weeks'}, {'measure': 'Change in serum phosphorus', 'timeFrame': '10 weeks'}, {'measure': 'Change in body fat mass index(BFMI)', 'timeFrame': '10 weeks'}, {'measure': 'Change in fat free mass index(FFMI)', 'timeFrame': '10 weeks'}, {'measure': 'Change in body cell mass(BCM)', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Diet', 'Inflammation', 'Malnutrition'], 'conditions': ['Inflammation', 'Malnutrition', 'Protein Energy Wasting Syndrome', 'Oxidative Stress', 'Diet Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of especial diet therapy "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission\n\nExclusion Criteria:\n\n* Hospitalization because of sepsis or surgery 3 months prior to intervention\n* Cirrhosis\n* Hepatitis virus infection\n* Human Immunodeficiency virus infection\n* Acquired Immunodeficiency Syndrome\n* Active malignancy\n* Active infection\n* Absence of communication\n* Mental Impairment\n* Terminal illness\n* Tube feedings\n* Total parenteral nutrition\n* Pregnancy\n* Not previously seen by a dietitian within 3 months prior to enrollment in the study\n* Not expected to be transplanted within 6 months after the enrollment in the study\n* Absence of malnutrition from a cause other than end stage renal disease(ESRD)\n* Psychiatric conditions, preventing adherence to intervention\n* Consuming immunosuppressive drugs or taking antioxidant supplements including Vitamin E, Vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid,Fish-oil extracts (omega-3 fatty acids), Soy extracts(isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts within 2 months prior to enrollment in the study'}, 'identificationModule': {'nctId': 'NCT01874106', 'briefTitle': 'Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '916425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet therapy', 'description': 'The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks.', 'interventionNames': ['Other: Diet Therapy']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Diet Therapy', 'type': 'OTHER', 'description': 'The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks.', 'armGroupLabels': ['Diet therapy']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shiraz University of Medical Sciences, Department of Nutrition', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Zohreh Mazloom, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shiraz University of Medical Sciences, Faculty of Nutrition'}, {'name': 'Mohammadmahdi Sagheb, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shiraz University of Medical Sciences, Nephrology Urology Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maryam Ekramzadeh, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Maryam Ekramzadeh, PhD', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}