Diarrhoea;AcuteESZnDiarrheaNCT04061538
Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
A study testing zinc sulfate in people with Diarrhoea;Acute and Diarrhea, Infantile, run by Instituto Nacional de Salud Publica, Mexico at 9 sites in Mexico.
Trial summary
This study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. One study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Diarrhoea;Acute, Diarrhea, Infantile
- What is being tested?
- zinc sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 529 participants
- Where
- 9 sitesMexico
- Study dates
- 9 Nov 2017to 31 Jan 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both sexes
- Children attended in the sentinel centers
- Clinical diagnosis of acute diarrhea disease
- Parents have not planned moving to other location in a time period of at least one year.
Who cannot join
- Deficient intestinal absorption syndrome
- Acrodermatitis enterohepatic
- Zinc sulfate hypersensitivity
- Leucine metabolic disorders
- Secondary lactose intolerance
- Galactosemia lactase primary deficiency
- Allergy to cow milk protein
- Children that are supplemented with zinc for the last 6 months
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Mexico9 sites
Hospital Pediatrico de Coyoacan
Mexico City, 04000
Instituto Nacional de Pediatria
Mexico City, 04530
Hospital Pediatrico La Villa
Mexico City, 07050
Hospital Pediatrico de Iztapalapa
Mexico City, 09070
Hospital Pediátrico de Tacubaya
Mexico City, 11870
Centro de Salud Cultura Maya
Mexico City, 14230
Centro de Salud San Andres Totoltepec
Mexico City, 14400
Centro de Salud Topilejo
Mexico City, 14500
Hospital Materno Infantil de Xochimilco
Mexico City, 16090
About this study
This study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. One study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that investigators will use as control.
Read the detailed description
In Mexico acute diarrheal diseases mortality in children continues to be a public health issue, being between the main causes of morbidity and mortality, with an important load for the health systems. Consequently, there exists a necessity for the implementation of alternate strategies for this condition, nutrition being one of the pillars to strengthen.
Zinc administration during the diarrhea episode is a simple intervention for clinical picture reduction and relapse. The recommendation of including zinc in the treatment of ADD is not part of the Mexican normativity. The evaluation of the efficacy of zinc administration in Mexican children is insufficient and a program or national strategy for zinc treatment does not exist.
The objective of this study is evaluates the efficacy of oral zinc sulfate administration, during the diarrhea clinic picture in children of Mexico City.
- Conditions
- Diarrhoea;Acute, Diarrhea, Infantile
- Being tested
- zinc sulfate, Placebo
- Keywords
- zinc sulfate, Children, acute diarrheal diseases
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulfateDietary supplement
zinc 20mg tablets
PlaceboDietary supplement
Also called Placebo (for zinc)
Sugar pill manufactured to mimic zinc 20mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Zinc sulfate | Experimental | Zinc sulfate 20 mg by mouth, once a day for 10 days Receives: Dietary Supplement: zinc sulfate |
| Placebo | Placebo comparator | Placebo tablet, once a day for 10 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea duration
Number of hours from the inclusion of the patient until the end of the diarrhea. The end of diarrhea was defined as the last diarrhea evacuation followed by a 48 hr period without diarrhea
Measured: 10 days
Stool frequency
Number of stools during during the acute diarrheic disease
Measured: 10 days
Secondary outcomes (2)
diarrheic disease recurrence
Number of acute diarrheal episode, after the first episode
Measured: 3 and 6 months
zinc serum concentration
Difference of zinc serum concentration after the oral treatment for 10 days with 20 mg of zinc, and its correlation with the duration of diarrhea , the number of total stools and relapse rates
Measured: 3, 9, 20, 31, 61, 91 and 121 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start9 Nov 2017
- Primary completion14 Sep 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhoea;AcuteStudies 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
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Principal investigator, Jorge Salmeron Castro, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Jorge Salmeron, PHD, Study chair, Universidad Nacional Autonoma de MexicoEdgar Sanchez, McS, Study director, Universidad Nacional Autonoma de MexicoMarcelino Esparza Aguilar, PhD, Principal investigator, National Institute of Pediatrics in Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061538
- Sponsor's protocol ID
- 1474
- Acronym
- ESZnDiarrhea
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
- ClinicalTrials.gov ID
- NCT04061538
- Acronym / sponsor ID
- ESZnDiarrhea / 1474
- Conditions
- Diarrhoea;Acute, Diarrhea, Infantile
- Keywords
- zinc sulfate, Children, acute diarrheal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- 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.
This study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. One study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that investigators will use as control.
Detailed description
In Mexico acute diarrheal diseases mortality in children continues to be a public health issue, being between the main causes of morbidity and mortality, with an important load for the health systems. Consequently, there exists a necessity for the implementation of alternate strategies for this condition, nutrition being one of the pillars to strengthen.
Zinc administration during the diarrhea episode is a simple intervention for clinical picture reduction and relapse. The recommendation of including zinc in the treatment of ADD is not part of the Mexican normativity. The evaluation of the efficacy of zinc administration in Mexican children is insufficient and a program or national strategy for zinc treatment does not exist.
The objective of this study is evaluates the efficacy of oral zinc sulfate administration, during the diarrhea clinic picture in children of Mexico City.
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 |
|---|---|---|
| Zinc sulfate | Experimental | Dietary Supplement: zinc sulfateZinc sulfate 20 mg by mouth, once a day for 10 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo tablet, once a day for 10 days |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Both sexes
- Children attended in the sentinel centers
- Clinical diagnosis of acute diarrhea disease
- Parents have not planned moving to other location in a time period of at least one year.
Key exclusion criteria (8 listed)
- Deficient intestinal absorption syndrome
- Acrodermatitis enterohepatic
- Zinc sulfate hypersensitivity
- Leucine metabolic disorders
- Secondary lactose intolerance
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 sulfatezinc 20mg tablets | Dietary supplement | Zinc sulfate |
| PlaceboAlso: Placebo (for zinc)Sugar pill manufactured to mimic zinc 20mg tablet | Dietary supplement | Placebo |
Primary outcome
Diarrhea duration
Time frame: 10 days
Number of hours from the inclusion of the patient until the end of the diarrhea. The end of diarrhea was defined as the last diarrhea evacuation followed by a 48 hr period without diarrhea
Stool frequency
Time frame: 10 days
Number of stools during during the acute diarrheic disease
2 secondary outcomes
diarrheic disease recurrence
Time frame: 3 and 6 months
zinc serum concentration
Time frame: 3, 9, 20, 31, 61, 91 and 121 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Jorge Salmeron, PHD study chair
Universidad Nacional Autonoma de Mexico
Edgar Sanchez, McS study director
Universidad Nacional Autonoma de Mexico
Marcelino Esparza Aguilar, PhD principal investigator
National Institute of Pediatrics in Mexico
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc sulfate in people with Diarrhoea;Acute and Diarrhea, Infantile, run by Instituto Nacional de Salud Publica, Mexico at 9 sites 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea duration (time frame: 10 days). The study lists 2 primary outcomes in all. 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 20 Aug 2019.