Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-30 @ 6:23 AM
Study NCT ID:
NCT04781868
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Nutrient Supplement for Radio-Protection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of gamma-H2Ax foci per PBMC nucleus', 'timeFrame': 'Three hours following radiation exposure', 'description': 'Number of gamma-H2Ax foci per PBMC nucleus three hours following radiation exposure'}], 'secondaryOutcomes': [{'measure': "Amount of amplifiable mtDNA in PBMC's", 'timeFrame': 'Three hours following radiation exposure', 'description': "Amount of amplifiable mtDNA in PBMC's three hours following radiation exposure"}, {'measure': "Abundance of mtDNA deletions in PBMC's", 'timeFrame': 'Three hours following radiation exposure', 'description': "Abundance of mtDNA deletions in PBMC's three hours following radiation exposure"}, {'measure': "Abundance of phosphorus-ATM in PBMC's", 'timeFrame': 'Three hours following radiation exposure', 'description': "Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oxidative Stress', 'DNA Damage, Radiation Induced', 'Radiation Exposure']}, 'descriptionModule': {'briefSummary': 'Exposure to radiation, such as during routine CTs, bone scans, or X-rays, causes oxidative stress which can damage the DNA (your genetic material) within your white blood cells. While the amount of DNA damage that may occur from one scan is not harmful to your overall health, there could be concerning damage in patients who are constantly exposed to this radiation. Currently, there is no way to prevent DNA damage during a medical scan. One potential way to fight the oxidative stress caused by radiation is to take an antioxidant before a scan. The purpose of this study is to see if a combination of antioxidants can protect someone from the damage that radiation causes to the DNA of their white blood cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 76 years.\n* Scheduled for bone scan procedure at the Juravinski Hospital.\n\nExclusion Criteria:\n\n* History of smoking within six months prior to study enrollment.\n* Known hypersensitivity reactions to any of the ingredients in the MNSRP.\n* Chemotherapy or radiation therapy within six months prior or one month following study enrollment.\n* Individuals currently taking vitamin or mineral supplements that contain antioxidants will be considered on a case-by-case basis but will be asked to refrain from intake for at least two weeks prior to partaking in this study.'}, 'identificationModule': {'nctId': 'NCT04781868', 'acronym': 'MNSRP', 'briefTitle': 'Multi-Nutrient Supplement for Radio-Protection', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Multi-Nutrient Supplement for Radio-Protection', 'orgStudyIdInfo': {'id': '13032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-nutrient supplement', 'interventionNames': ['Drug: Multi-nutrient supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supplement', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Multi-nutrient supplement', 'type': 'DRUG', 'description': 'Multi-nutrient supplement containing a combination of vitamins, minerals and antioxidants', 'armGroupLabels': ['Multi-nutrient supplement']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo supplement']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}