Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-01 @ 1:03 PM
Study NCT ID:
NCT03720756
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2018-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The efficacy of treatment methods will be assessed by comparing GERD-Health Related Quality of Life (HRQL) questionnaires before and after implementation of a nickel-free diet.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will undergo a patch test to determine if they are hypersensitive to nickel among other metabolites. Regardless of the results of the patch test, patients will be placed on a nickel-free diet for 8 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score', 'timeFrame': 'after 8 weeks on nickel-free diet', 'description': 'questionnaire to assess severity of GERD. Total Score: Calculated by summing the individual scores to questions 1-12. Greatest possible score (worst symptoms) = 60; Lowest possible score (no symptoms) = 0. For the purposes of our study, a score of 13 or above is considered symptomatic for GERD.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nickel-free', 'diet', 'GERD', 'Gastroesophageal Reflux'], 'conditions': ['Gastroesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '33219986', 'type': 'DERIVED', 'citation': 'Yousaf A, Hagen R, Mitchell M, Ghareeb E, Fang W, Correa R, Zinn Z, Gayam S. The effect of a low-nickel diet and nickel sensitization on gastroesophageal reflux disease: A pilot study. Indian J Gastroenterol. 2021 Apr;40(2):137-143. doi: 10.1007/s12664-020-01090-3. Epub 2020 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'There is little evidence on the effect of a nickel-free diet on gastroesophageal reflux disease (GERD). We hope to determine if a nickel-free diet improves GERD symptoms in patients with a nickel allergy by having patients complete a questionnaire on their GERD symptoms before and after initiation of 8 weeks on a nickel-free diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older with a history of GERD\n* owns a phone with a camera\n* has access to or is willing to sign up for MyChart\n* is symptomatic for GERD at time of visit as determined by a score of \\>12 on the GERD Health Related Quality of Life (GERD-HRQL) questionnaire. (Patients that are currently taking a proton pump inhibitor (PPI) they must have been on the PPI for at least 3 months.)\n\nExclusion Criteria:\n\n* less than 18 years of age\n* no not have access to MyChart\n* are not willing to sign up for MyChart\n* have taken an oral steroid within 4 weeks\n* have experienced a sunburn or had significant sun exposure within the last 4 weeks, or applied a topical steroid to the area that the past test will be applied (i.e. upper back or arm) in the last 4 weeks. No vulnerable populations will be included.'}, 'identificationModule': {'nctId': 'NCT03720756', 'briefTitle': 'Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.', 'orgStudyIdInfo': {'id': '1804080531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects WITH nickel-sensitivity', 'description': 'Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity.', 'interventionNames': ['Other: Nickel-free diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects WITHOUT nickel-sensitivity', 'description': 'Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity.', 'interventionNames': ['Other: Nickel-free diet']}], 'interventions': [{'name': 'Nickel-free diet', 'type': 'OTHER', 'description': 'Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.', 'armGroupLabels': ['Subjects WITH nickel-sensitivity', 'Subjects WITHOUT nickel-sensitivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26501', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'WVU Medicine University Town Center', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': "Physician's Office Center at Ruby Memorial, Digestive Diseases", 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan to make IPD available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director, Assistant Professor of Dermatology', 'investigatorFullName': 'Zachary Zinn', 'investigatorAffiliation': 'West Virginia University'}}}}