The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis

NCT02050646 | Completed

• 2 other identifiers: 1303011696YSOM Pediatrics Department
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis.

Conditions

Autoimmune Hepatitis

Keywords

Autoimmune hepatitis; Liver dysfunction; Elevated serum auto antibodies

Outcome Measures

Primary Outcomes (1)

• 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.

  26 days

Secondary Outcomes (1)

• Change from baseline in regulatory T cell function.

  26 days

Study Arms (2)

Low salt/ Liberal salt Diet

EXPERIMENTAL

Cross-over trial of liberal salt and low salt diet.

Other: Low Salt Diet; Other: Liberal salt diet

Liberal salt/Low salt diet

EXPERIMENTAL

Cross-over trial of low salt and liberal salt diet

Other: Low Salt Diet; Other: Liberal salt diet

Interventions

Low Salt Diet OTHER

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/Low salt diet; Low salt/ Liberal salt Diet

Liberal salt diet OTHER

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/Low salt diet; Low salt/ Liberal salt Diet

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chronic hepatitis C
• Decompensated Liver Disease

Sponsors & Collaborators

• Yale University: lead

MeSH Terms

Conditions

Hepatitis, Autoimmune; Liver Diseases

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Udeme Ekong, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: January 31, 2014
• Study Start: August 27, 2013
• Primary Completion: August 1, 2019
• Study Completion: June 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07