DysgeusiaZnDCPNCT02475928
Zinc Supplementation in Cirrhotic Patients
A study testing zinc gluconate and Nutritional education in people with Dysgeusia and Liver Cirrhosis, run by Fundación Clínica Médica Sur at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dysgeusia, Liver Cirrhosis
- What is being tested?
- zinc gluconate and Nutritional education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients by any etiology, with any dysgeusia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Medica Sur Clinic & Foundation
Mexico City, 14050
Varenka J Barbero-Becerra, PhD, 54247200, vbarberob@medicasur.org.mx
About this study
Official title: Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients
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.
- Conditions
- Dysgeusia, Liver Cirrhosis
- Being tested
- zinc gluconate, Placebo, Nutritional education
- Medical subject headings
- Dysgeusia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc gluconateDietary supplement
Zinc supplementation plus nutritional education
PlaceboDietary supplement
Nutritional educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 100 mg placebo | Placebo comparator | 100 mg Placebo plus nutritional education Receives: Dietary Supplement: Placebo; Behavioral: Nutritional education |
| 100 mg zinc supplement | Experimental | Nutritional education plus 100 mg of zinc gluconate Receives: Dietary Supplement: zinc gluconate; Behavioral: Nutritional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Presence of any taste disorder at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysgeusiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Clínica Médica Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norberto Carlos Chavez Taia, Fundación Clínica Médica Sur
- Investigators
- Norberto C Chávez-Tapia, PhD, Principal investigator, Medica Sur Clinic & FoundationEva Juárez-Hernández, Study director, Medica Sur Clinic & Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475928
- Sponsor's protocol ID
- Cirrhosis01
- Acronym
- ZnDCP
- Status last verified
- Feb 2019
- First submitted
- 29 Apr 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT02475928
- Acronym / sponsor ID
- ZnDCP / Cirrhosis01
- Conditions
- Dysgeusia, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fundación Clínica Médica SurUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mg placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Nutritional education100 mg Placebo plus nutritional education |
| 100 mg zinc supplement | Experimental | Dietary Supplement: zinc gluconate, Behavioral: Nutritional educationNutritional education plus 100 mg of zinc gluconate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhotic patients by any etiology, with any dysgeusia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc gluconateZinc supplementation plus nutritional education | Dietary supplement | 100 mg zinc supplement |
| Placebo | Dietary supplement | 100 mg placebo |
| Nutritional education | Behavioural | 100 mg placebo, 100 mg zinc supplement |
Primary outcome
Dysgeusia
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norberto C Chávez-Tapia, PhD principal investigator
Medica Sur Clinic & Foundation
Eva Juárez-Hernández study director
Medica Sur Clinic & Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc gluconate and Nutritional education in people with Dysgeusia and Liver Cirrhosis, run by Fundación Clínica Médica Sur at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norberto C Chávez-Tapia, PhD (54246850, nchavezt@medicasur.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysgeusia (time frame: Presence of any taste disorder at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.