Zinc Supplementation in Cirrhotic Patients
ZnDCP
Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 15, 2019
February 1, 2019
4.7 years
April 29, 2015
February 14, 2019
Conditions
Outcome Measures
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.
Presence of any taste disorder at 6 months
Study Arms (2)
100 mg placebo
PLACEBO COMPARATOR100 mg Placebo plus nutritional education
100 mg zinc supplement
EXPERIMENTALNutritional education plus 100 mg of zinc gluconate
Interventions
Zinc supplementation plus nutritional education
Eligibility Criteria
You may qualify if:
- Cirrhotic patients by any etiology, with any dysgeusia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medica Sur Clinic & Foundation
Mexico City, 14050, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norberto C Chávez-Tapia, PhD
Medica Sur Clinic & Foundation
- STUDY DIRECTOR
Eva Juárez-Hernández
Medica Sur Clinic & Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Obesity and Digestive Diseases Unit Chief
Study Record Dates
First Submitted
April 29, 2015
First Posted
June 19, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 15, 2019
Record last verified: 2019-02