Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-04-18 @ 7:38 AM
Study NCT ID:
NCT02686905
Status:
UNKNOWN
Last Update Posted:
2016-09-30
First Post:
2016-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin Supplementation After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-14', 'releaseDate': '2018-07-03'}], 'estimatedResultsFirstSubmitDate': '2018-07-03'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007501', 'term': 'Iron'}, {'id': 'D057968', 'term': 'Transdermal Patch'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2016-02-04', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Blood Glucose', 'timeFrame': '3 months', 'description': 'Glucose (mg/dL)'}, {'measure': 'Calcium Blood Value', 'timeFrame': '3 months', 'description': 'Calcium (mg/dL)'}, {'measure': 'Iron Blood Value', 'timeFrame': '3 months', 'description': 'Ferritin (ng/mL)'}, {'measure': 'Vitamin B12 Blood Value', 'timeFrame': '3 months', 'description': 'B12 (pg/mL)'}, {'measure': 'Vitamin D Blood Value', 'timeFrame': '3 months', 'description': 'Vitamin D, 25-Hydroxy (pg/mL)'}, {'measure': 'HbA1c Blood Value', 'timeFrame': '3 months', 'description': 'Hemoglobin A1c (%)'}, {'measure': 'Fat Mass Measurement', 'timeFrame': '3 months', 'description': 'Fat Mass (kg) via Tanita scale measurements'}, {'measure': 'Fat Free Mass Measurement', 'timeFrame': '3 months', 'description': 'Fat Free Mass (kg) via Tanita scale measurements'}, {'measure': 'Weight Measurement', 'timeFrame': '3 months', 'description': 'Weight (kg) via Tanita scale measurements'}, {'measure': 'Waist Circumference', 'timeFrame': '3 months', 'description': 'Waist circumference (cm)'}, {'measure': 'Hip Circumference', 'timeFrame': '3 months', 'description': 'Hip circumference (cm)'}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': '3 months', 'description': 'Statiometer measurement (cm)'}, {'measure': 'Total Body Water', 'timeFrame': '3 months', 'description': 'Total body water (kg) via Tanita scale measurements'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Complications of Bariatric Procedures', 'Avitaminosis']}, 'descriptionModule': {'briefSummary': 'The objectives in this study are to provide information on the efficacy of transdermal supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric patients, and to determine short-term body composition, HbA1c and fasting plasma glucose outcomes for patients after bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients currently approved for vertical sleeve or gastric bypass bariatric surgery\n* female patients should not be pregnant or plan to become pregnant\n\nExclusion Criteria:\n\n* metal objects in the body\n* current weight greater than 600lbs\n* previous bariatric (revision) surgery'}, 'identificationModule': {'nctId': 'NCT02686905', 'briefTitle': 'Vitamin Supplementation After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'California State Polytechnic University, Pomona'}, 'officialTitle': 'Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery', 'orgStudyIdInfo': {'id': 'VitaBari Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical vitamin patch', 'description': 'Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch', 'interventionNames': ['Dietary Supplement: PatchMD Vitamin D3/Calcium Patch', 'Dietary Supplement: PatchMD Multivitamin Patch', 'Dietary Supplement: PatchMD B12 Energy Plus Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Oral vitamins', 'description': 'Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12', 'interventionNames': ['Dietary Supplement: Chewable Multivitamin with Iron', 'Dietary Supplement: Chewable Calcium', 'Dietary Supplement: Quick Dissolve B12']}], 'interventions': [{'name': 'Chewable Multivitamin with Iron', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Oral Vitamin Supplementation'], 'description': 'Take daily: Chewable Multivitamin with Iron. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.', 'armGroupLabels': ['Oral vitamins']}, {'name': 'PatchMD Vitamin D3/Calcium Patch', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Transdermal Vitamin Supplementation'], 'description': 'Wear daily: PatchMD Vitamin D3/Calcium patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.', 'armGroupLabels': ['Topical vitamin patch']}, {'name': 'PatchMD Multivitamin Patch', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Transdermal Vitamin Supplementation'], 'description': 'Wear daily: PatchMD Multivitamin patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.', 'armGroupLabels': ['Topical vitamin patch']}, {'name': 'PatchMD B12 Energy Plus Patch', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Transdermal Vitamin Supplementation'], 'description': 'Wear daily: PatchMD B12 Energy Plus patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.', 'armGroupLabels': ['Topical vitamin patch']}, {'name': 'Chewable Calcium', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Oral Vitamin Supplementation'], 'description': 'Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.', 'armGroupLabels': ['Oral vitamins']}, {'name': 'Quick Dissolve B12', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Oral Vitamin Supplementation'], 'description': 'Take daily: Quick Dissolve B12. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.', 'armGroupLabels': ['Oral vitamins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92821', 'city': 'Brea', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Oliak, MD', 'role': 'CONTACT', 'email': 'info@droliak.com', 'phone': '714-582-2530'}, {'name': 'Rebecca McDorman, BS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Heather Garcia, BS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Corinne Worland, AA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jordyn Shubin', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oliak Center for Weight Loss', 'geoPoint': {'lat': 33.91668, 'lon': -117.90006}}], 'centralContacts': [{'name': 'Rebecca McDorman, BS', 'role': 'CONTACT', 'email': 'rlmcdorman@cpp.edu', 'phone': '9497023182'}], 'overallOfficials': [{'name': 'Bonny Burns-Whitmore, DrPH, RD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cal Poly Pomona'}, {'name': 'David M Oliak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oliak Center for Weight Loss'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California State Polytechnic University, Pomona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Student', 'investigatorFullName': 'Rebecca McDorman', 'investigatorAffiliation': 'California State Polytechnic University, Pomona'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-07-03', 'type': 'RELEASE'}, {'date': '2019-01-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rebecca McDorman, Graduate Student, California State Polytechnic University, Pomona'}}}}