Zinc Supplementation in Cirrhotic Patients (ZnDCP)

Fundación Clínica Médica Sur

Status: Unknown

Conditions: Liver Cirrhosis; Dysgeusia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: zinc gluconate; Behavioral: Nutritional education

Study type: Interventional

Funder types: Other

Identifiers

NCT02475928

Cirrhosis01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

100 mg placebo

Placebo Comparator group

Description:

100 mg Placebo plus nutritional education

Treatment:

Behavioral: Nutritional education

Dietary Supplement: Placebo

100 mg zinc supplement

Experimental group

Description:

Nutritional education plus 100 mg of zinc gluconate

Treatment:

Behavioral: Nutritional education

Dietary Supplement: zinc gluconate