DiarrheaNCT01306097
Zinc Supplementation and Severe and Recurrent Diarrhea
A study testing Zinc Supplement in people with Diarrhea, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Zinc Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Jan 2009to May 2010
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All 6 to 36 months old children without diarrhea at the time of study and without disease such as celiac
- Inflammatory bowl disease and hypersensitivity to milk
Who cannot join
- Diarrhea at the time of the study and background disease such as celiac, IBD or hypersensitivity to milk
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of medical sciences
Bandar Abbas, Hormozgan, 79145-3388
About this study
Official title: Evaluating the Impact of 3 Months Daily Zinc Supplementation on Incidence of Severe and Recurrent Diarrhea in 6 to 36 Months Age Children
Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas
Read the detailed description
Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas in 2009
- Conditions
- Diarrhea
- Being tested
- Zinc Supplement
- Keywords
- Zinc Supplement, Diarrhea, Sever Diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SupplementDrug
Also called Zinc sulfate, Oral Zinc
10mg daily for under 1 years old children and 20mg daily for above 1 years old children
| Study group | Role | What they receive |
|---|---|---|
| Zinc sulfate | Experimental | daily zinc supplementation for 3 months. (10mg daily for under 1 years old children and 20mg daily for above 1 years old children) Receives: Drug: Zinc Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea
Incidence, Duration and frequency
Measured: 1 years
Secondary outcomes (1)
Admission for diarrhea
Total number of admissions during the study period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionMay 2010
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Marzie Barchinejad, Principal investigator, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306097
- Sponsor's protocol ID
- Zinc supplementation
- Status last verified
- Jan 2009
- First submitted
- 28 Feb 2011
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
PubMed 36994923
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of 3 Months Daily Zinc Supplementation on Incidence of Severe and Recurrent Diarrhea in 6 to 36 Months Age Children
- ClinicalTrials.gov ID
- NCT01306097
- Acronym / sponsor ID
- Zinc supplementation
- Conditions
- Diarrhea
- Keywords
- Zinc Supplement, Diarrhea, Sever Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Mar 2011 (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.
Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas
Detailed description
Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas in 2009
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zinc sulfate | Experimental | Drug: Zinc Supplementdaily zinc supplementation for 3 months. (10mg daily for under 1 years old children and 20mg daily for above 1 years old children) |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All 6 to 36 months old children without diarrhea at the time of study and without disease such as celiac
- Inflammatory bowl disease and hypersensitivity to milk
Key exclusion criteria (1 listed)
- Diarrhea at the time of the study and background disease such as celiac, IBD or hypersensitivity to milk
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 SupplementAlso: Zinc sulfate, Oral Zinc10mg daily for under 1 years old children and 20mg daily for above 1 years old children | Drug | Zinc sulfate |
Primary outcome
Diarrhea
Time frame: 1 years
Incidence, Duration and frequency
1 secondary outcome
Admission for diarrhea
Time frame: 1 year
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 1 Mar 2011.
- Derived from this study: PubMed 36994923Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
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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.
Marzie Barchinejad principal investigator
Hormozgan University of Medical Sciences
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 Supplement in people with Diarrhea, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 1 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 1 Mar 2011. 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 Iran. 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. 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 (time frame: 1 years). 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 NCT01306097, 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 1 Mar 2011.