Zinc Supplementation in Cirrhotic Patients

NCT02475928 — Not applicable, Unknown, 70 participants, Fundación Clínica Médica Sur

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Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients

Registry	NCT02475928, acronym ZnDCP
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	70 (Estimated)
Sponsor	Fundación Clínica Médica Sur (Other)
Conditions	Dysgeusia, Liver Cirrhosis
Interventions	zinc gluconate, Placebo, Nutritional education (Dietary supplement, behavioral)
Dates	start 2015-04-01, primary completion 2019-12-01 (estimated), completion 2019-12-01 (estimated), first posted 2015-06-19, last updated 2019-02-15
Locations	1 site in Mexico

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
100 mg placebo	Placebo comparator	Dietary Supplement: Placebo; Behavioral: Nutritional education	100 mg Placebo plus nutritional education
100 mg zinc supplement	Experimental	Dietary Supplement: zinc gluconate; Behavioral: Nutritional education	Nutritional education plus 100 mg of zinc gluconate

zinc gluconate (Dietary supplement): Zinc supplementation plus nutritional education
Placebo (Dietary supplement)
Nutritional education (Behavioral)

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Medica Sur Clinic & Foundation	Mexico City	Mexico	Recruiting

+Investigators

Norberto C Chávez-Tapia, PhD, Principal investigator, Medica Sur Clinic & Foundation
Eva Juárez-Hernández, Study director, Medica Sur Clinic & Foundation