NCT01655121

Brief Summary

Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure. There are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of other diseases associated, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients. The implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

July 12, 2012

Last Update Submit

August 18, 2014

Conditions

Autoimmune HepatitisCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Nutritional Status

    Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculated mid-arm muscle circumference, fat mass, fat free mass total, intracellular and extracellular body water obtained by bioelectrical impedance analysis and individual vectors obtained by bioelectrical impedance vector analysis.

    Participants will be assessed for six months

Secondary Outcomes (2)

  • Minimal hepatic encephalopathy

    Participants will be assessed for six months

  • Quality of life

    Participants will be assessed for six months

Study Arms (2)

Autoimmune hepatitis (Non-cirrhotic)

EXPERIMENTAL

A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.

Dietary Supplement: High protein high fiber diet

Autoimmune hepatitis (Cirrhotic)

EXPERIMENTAL

A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.

Dietary Supplement: High protein high fiber diet

Interventions

High protein high fiber dietDIETARY_SUPPLEMENT

A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months. Each participant will receive nutritional counseling once month during six months.

Autoimmune hepatitis (Cirrhotic)Autoimmune hepatitis (Non-cirrhotic)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Autoimmune hepatitis (Non cirrhotic)
  • Diagnose of Autoimmune hepatitis
  • Presence of antinuclear antibody (ANA, SMA)
  • Biochemical evidence, based on elevation of transaminases
  • Biopsy compatible with Autoimmune hepatitis
  • Ambulatory patients
  • Autoimmune hepatitis (Cirrhotic)
  • Presence of antinuclear antibody (ANA, SMA)
  • Biochemical evidence, based on elevation of transaminases
  • Biopsy compatible with autoimmune cirrhosis
  • Hepatic cirrhosis by USD
  • Ambulatory patients
  • Diagnose of Autoimmune cirrhosis by two or more of the following criteria:
  • Albumin \<3.4g/dl
  • INR\>1.2
  • +2 more criteria

You may not qualify if:

  • Hospitalized patients
  • Overlapping syndrome with predominant primary biliary cirrhosis
  • Chronic renal failure
  • Hepatocellular carcinoma
  • Neuropsychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, D.f., 14000, Mexico

Location

MeSH Terms

Conditions

Hepatitis, AutoimmuneFibrosis

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aldo Torre Delgadillo, M.D. M.Sc

    INCMNSZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2012

First Posted

August 1, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

ME(1)