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Zinc Supplementation in Cirrhotic Patients (ZnDCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02475928
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):
Norberto Carlos Chavez Taia, Fundación Clínica Médica Sur

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dysgeusia Liver Cirrhosis Dietary Supplement: zinc gluconate Dietary Supplement: Placebo Behavioral: Nutritional education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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
Dietary Supplement: zinc gluconate
Zinc supplementation plus nutritional education

Behavioral: Nutritional education

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02475928

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Contact: Norberto C Chávez-Tapia, PhD 54246850
Contact: Eva Juárez-Hernández 54246850

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Medica Sur Clinic & Foundation Recruiting
Mexico City, Mexico, 14050
Contact: Varenka J Barbero-Becerra, PhD    54247200   
Sponsors and Collaborators
Fundación Clínica Médica Sur
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Principal Investigator: Norberto C Chávez-Tapia, PhD Medica Sur Clinic & Foundation
Study Director: Eva Juárez-Hernández Medica Sur Clinic & Foundation
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Responsible Party: Norberto Carlos Chavez Taia, Obesity and Digestive Diseases Unit Chief, Fundación Clínica Médica Sur Identifier: NCT02475928    
Other Study ID Numbers: Cirrhosis01
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms