Gastroesophageal RefluxNCT03720756
Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
A study testing Nickel-free diet in people with Gastroesophageal Reflux, run by West Virginia University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Nickel-free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2019to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WVU Medicine University Town Center
Morgantown, West Virginia, 26501
Physician's Office Center at Ruby Memorial, Digestive Diseases
Morgantown, West Virginia, 26506
About this study
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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Nickel-free diet
- Keywords
- nickel-free, diet, GERD, Gastroesophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nickel-free dietOther
Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Subjects WITH nickel-sensitivity | Experimental | Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity. Receives: Other: Nickel-free diet |
| Subjects WITHOUT nickel-sensitivity | Active comparator | Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity. Receives: Other: Nickel-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score
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.
Measured: after 8 weeks on nickel-free diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start3 Jan 2019
- Primary completion31 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary Zinn, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720756
- Sponsor's protocol ID
- 1804080531
- Status last verified
- Sep 2020
- First submitted
- 5 Oct 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make IPD available to other researchers.
Publications
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.
PubMed 33219986
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
- ClinicalTrials.gov ID
- NCT03720756
- Acronym / sponsor ID
- 1804080531
- Conditions
- Gastroesophageal Reflux
- Keywords
- nickel-free, diet, GERD, Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subjects WITH nickel-sensitivity | Experimental | Other: Nickel-free dietSubjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity. |
| Subjects WITHOUT nickel-sensitivity | Active comparator | Other: Nickel-free dietSubjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nickel-free dietSubjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects. | Other | Subjects WITH nickel-sensitivity, Subjects WITHOUT nickel-sensitivity |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 33219986Yousaf 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.
- Individual participant dataSharing planned: No. We do not plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nickel-free diet in people with Gastroesophageal Reflux, run by West Virginia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score (time frame: after 8 weeks on nickel-free diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.