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Status unknownNCT02475928ZnDCPUpdated Feb 15, 2019

Zinc Supplementation in Cirrhotic Patients

An interventional study of zinc gluconate and Placebo in Dysgeusia and Liver Cirrhosis, sponsored by Fundación Clínica Médica Sur. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Fundación Clínica Médica Sur · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dysgeusia
  • Liver Cirrhosis
03

In context

Dysgeusia

52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.

This study's planned enrollment of 70 is above the median of 49 across 28 interventional studies indexed under Dysgeusia.

Browse Dysgeusia studies →

Lead sponsor

Fundación Clínica Médica Sur is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cirrhotic patients by any etiology, with any dysgeusia

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Placebo comparator
    100 mg placebo

    100 mg Placebo plus nutritional education

    Dietary Supplement: Placebo · Behavioral: Nutritional education

  • Experimental
    100 mg zinc supplement

    Nutritional education plus 100 mg of zinc gluconate

    Dietary Supplement: zinc gluconate · Behavioral: Nutritional education

Interventions

  • Dietary supplementzinc gluconate

    Zinc supplementation plus nutritional education

  • Dietary supplementPlacebo
  • BehavioralNutritional education
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Presence of any taste disorder at 6 months

07

Study locations

1 of 1 sites recruiting
  • Medica Sur Clinic & Foundation
    Mexico City, 14050, Mexico
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02475928
Lead sponsor
Fundación Clínica Médica Sur
Responsible party
Norberto Carlos Chavez Taia (Obesity and Digestive Diseases Unit Chief, Fundación Clínica Médica Sur) — Principal investigator
First posted
Jun 19, 2015
Start date
Apr 2015
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 15, 2019

Study contacts

Norberto C Chávez-Tapia, PhD
Contact
nchavezt@medicasur.org.mx
54246850
Eva Juárez-Hernández
Contact
evajuarezh@hotmail.com
54246850
Norberto C Chávez-Tapia, PhD
principal investigator · Medica Sur Clinic & Foundation
Eva Juárez-Hernández
study director · Medica Sur Clinic & Foundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Gluconic acid

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