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Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720756
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Zachary Zinn, West Virginia University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Other: Nickel-free diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Nickel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subjects WITH nickel-sensitivity
Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity.
 Other: Nickel-free diet
Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.
Active Comparator: Subjects WITHOUT nickel-sensitivity
Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity.
 Other: Nickel-free diet
Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.


Outcome Measures
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Primary Outcome Measures :
  1. Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score [ Time Frame: after 8 weeks on nickel-free diet ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 years or older with a history of GERD
  • owns a phone with a camera
  • has access to or is willing to sign up for MyChart
  • 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.)

Exclusion Criteria:

  • less than 18 years of age
  • no not have access to MyChart
  • are not willing to sign up for MyChart
  • have taken an oral steroid within 4 weeks
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720756


Locations
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United States, West Virginia
WVU Medicine University Town Center
Morgantown, West Virginia, United States, 26501
Physician's Office Center at Ruby Memorial, Digestive Diseases
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zachary Zinn, Program Director, Assistant Professor of Dermatology, West Virginia University
ClinicalTrials.gov Identifier: NCT03720756    
Other Study ID Numbers: 1804080531
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zachary Zinn, West Virginia University:
nickel-free
diet
GERD
Gastroesophageal Reflux
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Nickel
Trace Elements
Micronutrients
Physiological Effects of Drugs