Zinc Supplementation in Cirrhotic Patients

Not Applicable

• Conditions: Dysgeusia; Liver Cirrhosis
• Interventions: Dietary Supplement: zinc gluconate; Dietary Supplement: Placebo; Behavioral: Nutritional education

• Registration Number: NCT02475928
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-19
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 mg zinc supplement	Nutritional education	Nutritional education plus 100 mg of zinc gluconate
100 mg zinc supplement	zinc gluconate	Nutritional education plus 100 mg of zinc gluconate
100 mg placebo	Nutritional education	100 mg Placebo plus nutritional education
100 mg placebo	Placebo	100 mg Placebo plus nutritional education

Primary Outcome Measures

Name	Time	Method
Dysgeusia	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.

Trial Locations

Locations (1)

Medica Sur Clinic & Foundation; 🇲🇽 Mexico City, Mexico