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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02475928
Other study ID # Cirrhosis01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date December 2019

Study information

Verified date February 2019
Source Fundación Clínica Médica Sur
Contact Norberto C Chávez-Tapia, PhD
Phone 54246850
Email nchavezt@medicasur.org.mx
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
zinc gluconate
Zinc supplementation plus nutritional education
Placebo

Behavioral:
Nutritional education


Locations

Country Name City State
Mexico Medica Sur Clinic & Foundation Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Fundación Clínica Médica Sur

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dysgeusia 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
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