DiarrheaPhase 4ZAZONCT01791608
Zinc Sulphate vs. Zinc Amino Acid Chelate
A Phase 4 study testing Zinc sulfate as dietary supplementation, Zinc amino acid chelate as dietary supplementation and Milk without fortification without zinc in people with Diarrhea and Acute Respiratory Infection, run by CES University at 1 site in Colombia.
Trial summary
Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years. Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Acute Respiratory Infection
- What is being tested?
- Zinc sulfate as dietary supplementation, Zinc amino acid chelate as dietary supplementation and Milk without fortification without zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2012to Nov 2012
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who
- Belong to institute FAN in Medellín
- Attend full time to institute FAN (eight hours)
- Have 2 to 5 years
Who cannot join
- Children who
- Children at the began of the study are with acute diarrheal disease and acute respiratory infection.
- Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease.
- Failure to attend the educational institution for more than 10 days
- No consumption of zinc supplementation for more than 10 days, because of insistence to the school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years.
Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.
Read more
Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.
We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.
- Conditions
- Diarrhea, Acute Respiratory Infection
- Being tested
- Zinc sulfate as dietary supplementation, Zinc amino acid chelate as dietary supplementation, Milk without fortification without zinc
- Keywords
- Child, Preschool, Dietary Zinc, Zinc sulfate, zinc-glycine chelate
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc sulfate as dietary supplementationDietary supplement
Zinc sulfate as dietary supplementation
Zinc amino acid chelate as dietary supplementationDietary supplement
Zinc amino acid chelate as dietary supplementation
Milk without fortification without zincDietary supplement
Also called Milk without zinc
Milk without fortification
| Study group | Role | What they receive |
|---|---|---|
| Zinc sulphate | Active comparator | Preschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate Receives: Dietary Supplement: Zinc sulfate as dietary supplementation |
| Zinc Amino Acid Chelate | Experimental | Preschool children healthy enrolled in FAN Foundation of Medellin , which will be supplied with zinc amino acid chelate Receives: Dietary Supplement: Zinc amino acid chelate as dietary supplementation |
| Milk without fortification | Placebo comparator | Milk without zinc Receives: Dietary Supplement: Milk without fortification without zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence acute diarrheal disease and acute respiratory infection
Preschool children will drink fortified milk with zinc amino acid chelate, zinc sulfate or milk without fortification. Fortnightly monitoring will be investigating the presence of infection (acute diarrheal disease and respiratory infections). Supervision and monitoring will be carried out for four months.
Measured: Up to 16 weeks
Secondary outcomes (1)
Adverse reaction
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea and vomiting.
Measured: Fortnightly. During 4 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutreva S.A.S., Foundation Child Care - FAN
- Responsible party
- Principal investigator, Juliana Sanchez,MG, CES University
- Investigators
- Liliana LM Montoya, Master, Study director, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791608
- Sponsor's protocol ID
- ZAZO-01
- Acronym
- ZAZO
- Status last verified
- Feb 2013
- First submitted
- 13 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanchez J, Villada OA, Rojas ML, Montoya L, Diaz A, Vargas C, Chica J, Herrera AA. [Effect of zinc amino acid chelate and zinc sulfate in the incidence of respiratory infection and diarrhea among preschool children in child daycare centers]. Biomedica. 2014 Jan-Mar;34(1):79-91. doi: 10.1590/S0120-41572014000100011. Spanish.
PubMed 24967861
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
- ClinicalTrials.gov ID
- NCT01791608
- Acronym / sponsor ID
- ZAZO / ZAZO-01
- Conditions
- Diarrhea, Acute Respiratory Infection
- Keywords
- Child, Preschool, Dietary Zinc, Zinc sulfate, zinc-glycine chelate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- Nutreva S.A.S., Foundation Child Care - FAN
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Feb 2013 (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.
Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years.
Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.
Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.
We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zinc sulphate | Active comparator | Dietary Supplement: Zinc sulfate as dietary supplementationPreschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate |
| Zinc Amino Acid Chelate | Experimental | Dietary Supplement: Zinc amino acid chelate as dietary supplementationPreschool children healthy enrolled in FAN Foundation of Medellin , which will be supplied with zinc amino acid chelate |
| Milk without fortification | Placebo comparator | Dietary Supplement: Milk without fortification without zincMilk without zinc |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who
- Belong to institute FAN in Medellín
- Attend full time to institute FAN (eight hours)
- Have 2 to 5 years
Key exclusion criteria (5 listed)
- Children who
- Children at the began of the study are with acute diarrheal disease and acute respiratory infection.
- Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease.
- Failure to attend the educational institution for more than 10 days
- No consumption of zinc supplementation for more than 10 days, because of insistence to the school
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 sulfate as dietary supplementationZinc sulfate as dietary supplementation | Dietary supplement | Zinc sulphate |
| Zinc amino acid chelate as dietary supplementationZinc amino acid chelate as dietary supplementation | Dietary supplement | Zinc Amino Acid Chelate |
| Milk without fortification without zincAlso: Milk without zincMilk without fortification | Dietary supplement | Milk without fortification |
Primary outcome
Incidence acute diarrheal disease and acute respiratory infection
Time frame: Up to 16 weeks
Preschool children will drink fortified milk with zinc amino acid chelate, zinc sulfate or milk without fortification. Fortnightly monitoring will be investigating the presence of infection (acute diarrheal disease and respiratory infections). Supervision and monitoring will be carried out for four months.
1 secondary outcome
Adverse reaction
Time frame: Fortnightly. During 4 months of intervention
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 15 Feb 2013.
- Derived from this study: PubMed 24967861Sanchez J, Villada OA, Rojas ML, Montoya L, Diaz A, Vargas C, Chica J, Herrera AA. [Effect of zinc amino acid chelate and zinc sulfate in the incidence of respiratory infection and diarrhea among preschool children in child daycare centers]. Biomedica. 2014 Jan-Mar;34(1):79-91. doi: 10.1590/S0120-41572014000100011. Spanish.
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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.
Liliana LM Montoya, Master study director
CES University
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 as dietary supplementation, Zinc amino acid chelate as dietary supplementation and Milk without fortification without zinc in people with Diarrhea and Acute Respiratory Infection, run by CES University at 1 site in Colombia.
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 5 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 15 Feb 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 Colombia. 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?
Incidence acute diarrheal disease and acute respiratory infection (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01791608, which also lists 1 linked publication.
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 2013.