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Zinc Supplementation in Cirrhotic Patients (ZnDCP)

Primary Purpose

Dysgeusia, Liver Cirrhosis

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

zinc gluconate

Placebo

Nutritional education

About this trial

This is an interventional treatment trial for Dysgeusia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Medica Sur Clinic & FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

100 mg placebo

100 mg zinc supplement

Arm Description

100 mg Placebo plus nutritional education

Nutritional education plus 100 mg of zinc gluconate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02475928

First Posted

April 29, 2015

Last Updated

February 14, 2019

Sponsor

Fundación Clínica Médica Sur

1. Study Identification

Unique Protocol Identification Number

NCT02475928

Brief Title

Zinc Supplementation in Cirrhotic Patients

Acronym

ZnDCP

Official Title

Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundación Clínica Médica Sur

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysgeusia, Liver Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

100 mg placebo

Arm Type

Placebo Comparator

Arm Description

100 mg Placebo plus nutritional education

Arm Title

100 mg zinc supplement

Arm Type

Experimental

Arm Description

Nutritional education plus 100 mg of zinc gluconate

Intervention Type

Dietary Supplement

Intervention Name(s)

zinc gluconate

Intervention Description

Zinc supplementation plus nutritional education

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Type

Behavioral

Intervention Name(s)

Nutritional education

Primary Outcome Measure Information:

Title

Dysgeusia

Description

Evaluation of presence of any taste disorder, according to questionnaires and evaluation of perception and recognition thresholds with ascending molar concentrations of basic tastes.

Time Frame

Presence of any taste disorder at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Norberto C Chávez-Tapia, PhD

Phone

54246850

nchavezt@medicasur.org.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Eva Juárez-Hernández

Phone

54246850

evajuarezh@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norberto C Chávez-Tapia, PhD

Organizational Affiliation

Medica Sur Clinic & Foundation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eva Juárez-Hernández

Organizational Affiliation

Medica Sur Clinic & Foundation

Official's Role

Study Director

Facility Information:

Facility Name

Medica Sur Clinic & Foundation

City

Mexico City

ZIP/Postal Code

14050

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Varenka J Barbero-Becerra, PhD

Phone

54247200

vbarberob@medicasur.org.mx

12. IPD Sharing Statement

Learn more about this trial

Zinc Supplementation in Cirrhotic Patients

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