Zinc Supplementation in Cirrhotic Patients

NCT ID: NCT02475928

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to evaluate the effect of zinc supplementation in the treatment for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.

Detailed Description

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Taste disorders are symptomatologies in patients with cirrhosis, these have a direct effect in modification of food consumption, increasing weight loss, anorexia and malnutrition, which impacts in decompensation rates and mortality.

It has been proposed that zinc deficiency is one of the causes for development of taste disorders. The aim of this study is to describe the presence of taste disorders in patients with cirrhosis and evaluate the effect of zinc supplementation in treatment of taste disorders, and in progression of chronic liver disease.

Conditions

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Dysgeusia Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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100 mg placebo

100 mg Placebo plus nutritional education

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Nutritional education

Intervention Type BEHAVIORAL

100 mg zinc supplement

Nutritional education plus 100 mg of zinc gluconate

Group Type EXPERIMENTAL

zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Zinc supplementation plus nutritional education

Nutritional education

Intervention Type BEHAVIORAL

Interventions

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zinc gluconate

Zinc supplementation plus nutritional education

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Nutritional education

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Cirrhotic patients by any etiology, with any dysgeusia

Exclusion Criteria

* Patients with hepatic encephalopathy at the time of dysgeusia evaluation
* Patients with any neurological disease
* Patients with respiratory diseases ath the time of dysgeusia evaluation
* Patients with active alcohol consumption
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Clínica Médica Sur

OTHER

Sponsor Role lead

Responsible Party

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Norberto Carlos Chavez Taia

Obesity and Digestive Diseases Unit Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norberto C Chávez-Tapia, PhD

Role: PRINCIPAL_INVESTIGATOR

Medica Sur Clinic & Foundation

Eva Juárez-Hernández

Role: STUDY_DIRECTOR

Medica Sur Clinic & Foundation

Locations

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Medica Sur Clinic & Foundation

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Norberto C Chávez-Tapia, PhD

Role: CONTACT

Eva Juárez-Hernández

Role: CONTACT

Facility Contacts

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Varenka J Barbero-Becerra, PhD

Role: primary

Other Identifiers

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Cirrhosis01

Identifier Type: -

Identifier Source: org_study_id

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