Zinc Supplementation in Cirrhotic Patients (ZnDCP)

February 14, 2019 updated by: Norberto Carlos Chavez Taia, Fundación Clínica Médica Sur

Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14050
        • Recruiting
        • Medica Sur Clinic & Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 100 mg placebo
100 mg Placebo plus nutritional education
Dietary supplement: Placebo
Behavioral: Nutritional education
Experimental: 100 mg zinc supplement
Nutritional education plus 100 mg of zinc gluconate
Behavioral: Nutritional education
Dietary supplement: zinc gluconate
Zinc supplementation plus nutritional education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysgeusia
Time Frame: Presence of any taste disorder at 6 months
Evaluation of presence of any taste disorder, according to questionnaires and evaluation of perception and recognition thresholds with ascending molar concentrations of basic tastes.
Presence of any taste disorder at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Clínica Médica Sur

Investigators

  • Principal Investigator: Norberto C Chávez-Tapia, PhD, Medica Sur Clinic & Foundation
  • Study Director: Eva Juárez-Hernández, Medica Sur Clinic & Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cirrhosis01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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