Acute DiarrheaPhase 4NCT01571856
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
A Phase 4 study testing Zinc Sulfate in people with Acute Diarrhea and Acute Gastroenteritis, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
Trial summary
The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Acute Diarrhea, Acute Gastroenteritis
- What is being tested?
- Zinc Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBolivia
- Study dates
- Jul 2011to May 2013
- Phase
- Phase 4
- 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 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all acute diarrhea
Who cannot join
- Severe malnourishment
- Severe dehydration
- Systemic infections
- coinfections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.
The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Read the detailed description
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months.
Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.
- Conditions
- Acute Diarrhea, Acute Gastroenteritis
- Being tested
- Zinc Sulfate, placebo
- Keywords
- Acute Diarrhea, Zinc, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDrug
Also called Suplizinc
zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.
placeboOther
cornstarch powder diluted in distilled water, dosage 2.5 ml per day
| Study group | Role | What they receive |
|---|---|---|
| zinc sulfate | Active comparator | zinc sulphate solution. Receives: Drug: Zinc Sulfate |
| cornstarch solution | Placebo comparator | cornstarch powder diluted in distilled water Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of diarrheal episode
duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.
Measured: five days
Secondary outcomes (2)
duration of hospitalization
participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured: 5 days
weight of stool
we expected the weight of the stool will diminish by about 5 days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Pediatrico Albina de Patino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Grandy, Centro Pediatrico Albina de Patino
- Investigators
- Giuseppe Grandy, MD MSc, Study director, Centro Pediatrico Albina de PatinoZaida Cama, MD, Study chair, Centro Pediatrico Albina Ptino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571856
- Sponsor's protocol ID
- protzinc2012
- Status last verified
- May 2013
- First submitted
- 3 Apr 2012
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.
- ClinicalTrials.gov ID
- NCT01571856
- Acronym / sponsor ID
- protzinc2012
- Conditions
- Acute Diarrhea, Acute Gastroenteritis
- Keywords
- Acute Diarrhea, Zinc, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centro Pediatrico Albina de PatinoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Apr 2012 (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 determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Detailed description
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months.
Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc sulfate | Active comparator | Drug: Zinc Sulfatezinc sulphate solution. |
| cornstarch solution | Placebo comparator | Other: placebocornstarch powder diluted in distilled water |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all acute diarrhea
Key exclusion criteria (4 listed)
- Severe malnourishment
- Severe dehydration
- Systemic infections
- coinfections
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 SulfateAlso: Suplizinczinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day. | Drug | zinc sulfate |
| placebocornstarch powder diluted in distilled water, dosage 2.5 ml per day | Other | cornstarch solution |
Primary outcome
duration of diarrheal episode
Time frame: five days
duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.
2 secondary outcomes
duration of hospitalization
Time frame: 5 days
weight of stool
Time frame: 5 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 7 May 2013.
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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.
Giuseppe Grandy, MD MSc study director
Centro Pediatrico Albina de Patino
Zaida Cama, MD study chair
Centro Pediatrico Albina Ptino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc Sulfate in people with Acute Diarrhea and Acute Gastroenteritis, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
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: finished, as of the sponsor's last update on 7 May 2013. 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 Bolivia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
duration of diarrheal episode (time frame: five days). 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 7 May 2013.