Autoimmune HepatitisNCT02050646
The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis
A study testing Low Salt Diet and Liberal salt diet in people with Autoimmune Hepatitis, run by Yale University.
Trial summary
The purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis. Read more about this study
- Who is it for?
- Ages 1 year to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- Low Salt Diet and Liberal salt diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2013to Jun 2021
- 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 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults 18-50 years of age
- Children 1-17 years of age
- ALT and/or ALP/GGT level > 2X upper limit of normal
- ANA or SMA >/= 1:40
- ANA or SMA >/= 1:80
- or LKM >/= 1:40
- or SLA positive
- IgG > upper limit of normal
Who cannot join
- Chronic hepatitis C
- Decompensated Liver Disease
About this study
The purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis.
Read the detailed description
The etiology of autoimmune hepatitis (AIH) is unknown although both genetic and environmental factors are thought to be involved. A defect in immune regulation affecting regulatory T cells (Tregs) has been demonstrated in AIH. Tregs function in the maintenance of immune homeostasis by controlling autoreactive immune responses to self-antigens.
Rationale: the western diet has been postulated as a potential environmental risk factor for the increasing incidence of autoimmune diseases in developed countries. Data from the investigators' laboratory also suggests that increased dietary salt intake might represent an environmental risk factor for the development of autoimmune diseases through the induction of pathogenic Th17 cells. The dramatic in vitro effects of high salt on the induction of pathogenic Th17 cells from naïve human CD4 cells {Kleinewietfeld, Hafler. Nature. 2013 Apr 25;496(7446):518-22. doi: 10.1038/nature11868.}, and block of in vitro Treg suppression, in line with in vivo effects on worsening murine experimental autoimmune encephalomyelitis (EAE), have prompted the investigators to examine the effects of increased dietary sodium chloride in a human in vivo system.
The investigators hypothesize that excess dietary salt may function as an environmental trigger that favors induction and expansion of pathogenic Th17 cells and leads to functional impairment of Tregs, thereby favoring development of autoimmunity. The investigators aim to study their established in vitro model in humans by altering the salt intake in patients over a 20-day period.
- Conditions
- Autoimmune Hepatitis
- Being tested
- Low Salt Diet, Liberal salt diet
- Keywords
- Autoimmune hepatitis, Liver dysfunction, Elevated serum auto antibodies
- Medical subject headings
- Hepatitis, Autoimmune, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Salt DietOther
On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
Liberal salt dietOther
On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
| Study group | Role | What they receive |
|---|---|---|
| Low salt/ Liberal salt Diet | Experimental | Cross-over trial of liberal salt and low salt diet. Receives: Other: Low Salt Diet; Other: Liberal salt diet |
| Liberal salt/Low salt diet | Experimental | Cross-over trial of low salt and liberal salt diet Receives: Other: Low Salt Diet; Other: Liberal salt diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in production of pathogenic TH17 cells.
Measuring TH17 cells by flow cytometry and qRT-PCR. There are no known normal ranges. The investigator will calculate the change by observing the difference from baseline values.
Measured: 26 days
Secondary outcomes (1)
Change from baseline in regulatory T cell function.
Measuring T cell function by flow cytometry. There are no known normal ranges. The investigator will calculate the change by observing the difference from baseline values.
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study start27 Aug 2013
- Primary completionAug 2019
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Yale 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Udeme Ekong, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050646
- Sponsor's protocol ID
- 1303011696
- Other IDs
- YSOM Pediatrics Department
- Status last verified
- Jul 2021
- First submitted
- 4 Nov 2013
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT02050646
- Acronym / sponsor ID
- 1303011696
- Conditions
- Autoimmune Hepatitis
- Keywords
- Autoimmune hepatitis, Liver dysfunction, Elevated serum auto antibodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
The purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis.
Detailed description
The etiology of autoimmune hepatitis (AIH) is unknown although both genetic and environmental factors are thought to be involved. A defect in immune regulation affecting regulatory T cells (Tregs) has been demonstrated in AIH. Tregs function in the maintenance of immune homeostasis by controlling autoreactive immune responses to self-antigens.
Rationale: the western diet has been postulated as a potential environmental risk factor for the increasing incidence of autoimmune diseases in developed countries. Data from the investigators' laboratory also suggests that increased dietary salt intake might represent an environmental risk factor for the development of autoimmune diseases through the induction of pathogenic Th17 cells. The dramatic in vitro effects of high salt on the induction of pathogenic Th17 cells from naïve human CD4 cells {Kleinewietfeld, Hafler. Nature. 2013 Apr 25;496(7446):518-22. doi: 10.1038/nature11868.}, and block of in vitro Treg suppression, in line with in vivo effects on worsening murine experimental autoimmune encephalomyelitis (EAE), have prompted the investigators to examine the effects of increased dietary sodium chloride in a human in vivo system.
The investigators hypothesize that excess dietary salt may function as an environmental trigger that favors induction and expansion of pathogenic Th17 cells and leads to functional impairment of Tregs, thereby favoring development of autoimmunity. The investigators aim to study their established in vitro model in humans by altering the salt intake in patients over a 20-day period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low salt/ Liberal salt Diet | Experimental | Other: Low Salt Diet, Other: Liberal salt dietCross-over trial of liberal salt and low salt diet. |
| Liberal salt/Low salt diet | Experimental | Other: Low Salt Diet, Other: Liberal salt dietCross-over trial of low salt and liberal salt diet |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adults 18-50 years of age
- Children 1-17 years of age
- ALT and/or ALP/GGT level > 2X upper limit of normal
- ANA or SMA >/= 1:40
- ANA or SMA >/= 1:80
Key exclusion criteria (2 listed)
- Chronic hepatitis C
- Decompensated Liver Disease
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 |
|---|---|---|
| Low Salt DietOn Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet. | Other | Liberal salt/Low salt diet, Low salt/ Liberal salt Diet |
| Liberal salt dietOn Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet. | Other | Liberal salt/Low salt diet, Low salt/ Liberal salt Diet |
Primary outcome
Change from baseline in production of pathogenic TH17 cells.
Time frame: 26 days
Measuring TH17 cells by flow cytometry and qRT-PCR. There are no known normal ranges. The investigator will calculate the change by observing the difference from baseline values.
1 secondary outcome
Change from baseline in regulatory T cell function.
Time frame: 26 days
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 28 Jul 2021.
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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.
Udeme Ekong, MD, MPH principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Low Salt Diet and Liberal salt diet in people with Autoimmune Hepatitis, run by Yale University.
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 8 inclusion and 2 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 from baseline in production of pathogenic TH17 cells. (time frame: 26 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021.