Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04054505
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2019-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001361', 'term': 'Avitaminosis'}], 'ancestors': [{'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Unmarked plan packet'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Triple blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2019-08-10', 'studyFirstSubmitQcDate': '2019-08-10', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.', 'timeFrame': 'Three months', 'description': 'Effectiveness of EZPAK in Raising Circulating Serum Levels'}], 'secondaryOutcomes': [{'measure': 'Control group', 'timeFrame': 'Three months', 'description': 'Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.'}, {'measure': 'Placebo group', 'timeFrame': 'Three months', 'description': 'Levels of Circulating Serum VitaminA1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin Deficiency']}, 'referencesModule': {'references': [{'pmid': '34540877', 'type': 'DERIVED', 'citation': 'Nenseth HZ, Sahu A, Saatcioglu F, Osguthorpe S. A Nutraceutical Formula Is Effective in Raising the Circulating Vitamin and Mineral Levels in Healthy Subjects: A Randomized Trial. Front Nutr. 2021 Sep 1;8:703394. doi: 10.3389/fnut.2021.703394. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to correlate the findings of an early study with current data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '26 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Healthy volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF-1 and FT-3 are within normal limits.\n\nA1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL\n\nExclusion Criteria: Volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3 are outside normal limits.\n\nA1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL -'}, 'identificationModule': {'nctId': 'NCT04054505', 'briefTitle': 'Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Optimal Health Research'}, 'officialTitle': 'Quantitative Analysis of Clinical Data for the Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.', 'orgStudyIdInfo': {'id': 'EZ102018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin A', 'description': 'Rise or fall of Vitamin A after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin E', 'description': 'Rise or fall of Vitamin E after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin B1', 'description': 'Rise or fall of Vitamin B1 after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin B2', 'description': 'Rise or fall of Vitamin B2 after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin B6', 'description': 'Rise or fall of Vitamin B6 after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin B12', 'description': 'Rise or fall of Vitamin B12 after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin C', 'description': 'Rise or fall of Vitamin C after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Rise or fall of Vitamin D after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium', 'description': 'Rise or fall of Calcium after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iron', 'description': 'Rise or fall of Iron after three months', 'interventionNames': ['Dietary Supplement: EZPAK', 'Dietary Supplement: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'IGF1', 'description': 'Rise or fall of IGF1 after three months'}, {'type': 'NO_INTERVENTION', 'label': 'FT-3', 'description': 'Rise or fall of FT-3 after three months'}], 'interventions': [{'name': 'EZPAK', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One packet with breakfast for three months', 'armGroupLabels': ['Calcium', 'Iron', 'Vitamin A', 'Vitamin B1', 'Vitamin B12', 'Vitamin B2', 'Vitamin B6', 'Vitamin C', 'Vitamin D', 'Vitamin E']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One packet with breakfast for three months', 'armGroupLabels': ['Calcium', 'Iron', 'Vitamin A', 'Vitamin B1', 'Vitamin B12', 'Vitamin B2', 'Vitamin B6', 'Vitamin C', 'Vitamin D', 'Vitamin E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Optimal Health Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Steven Osguthorpe, ND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optimal Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimal Health Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}