Acute Watery DiarrhoeaPhase 3NCT00325247
Efficacy of Zinc Therapy in Acute Diarrhoea in Young Children
A Phase 3 study testing ZINC in people with Acute Watery Diarrhoea, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Acute Watery Diarrhoea
- What is being tested?
- ZINC
- How many people
- 2,050 participants
- Where
- 1 siteBangladesh
- Study dates
- Feb 2005to May 2006
- Phase
- Phase 3
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than 5 years with acute watery diarrhoea less than 48 h of duration
- No medication received other than ORS or home solution
- Absence of complication or co-morbidities.
- Absence of severe dehydration
Who cannot join
- Age greater than 5 years
- Diarrhoea more than 48 h duration
- Unable to eat or drink
- Already received multiple treatment including zinc
- Presence of co-morbidities
- Severe dehydration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Short Course Zinc Therapy (5 vs 10 d) With 20 mg Elemental Zinc Daily in the Treatment of Acute Diarrhoea: A Double-blind Individually Randomized Controlled Community Trial.
Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc.
The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea.
Read more
This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area.
The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure.
Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.
Read the detailed description
The proposed study will use a prospective, double-blind, randomized design in which all study children with diarrhoea will receive zinc treatment for the first 5 days and then they will receive either zinc or a placebo for the second 5 days of the 10 day course according to random allocation to evaluate the efficacy of shorter course of zinc treatment (5 days vs 10 days) during diarrhoea in children less than 5 years of age. Children with diarrhoea will be detected through routine daily surveillance by trained Female Field Worker (FFW) in the study area and will be enrolled into the study soon after detection and the informed consent of the parent is obtained. Zinc will be administered daily by FFWs as 20 mg elemental zinc as single dose for 5 or 10 days. Dispersible zinc tablets in blister pack produced by Nutriset® used in the national zinc scaling up project will be used for the study. The placebo will also be dispersible tablets identical and undistinguishable from zinc tablet in terms of appearance, colour, taste and flavour will be obtained from the same manufacturer. The first episode of a child will be treated as part of this study although children will be encouraged to take zinc if s/he develops diarrhoea during the study period. The dose is about double the Recommended Daily Allowance (RDA) for the children which has been chosen considering the poor zinc status of the children to be included and replenishment of possible loss of zinc during diarrhoeal episode and also to be consistent with the current recommendation in the zinc scaling up initiative. Outcome will be assessed daily during routine visit using a precoded questionnaire. Although all the children will receive zinc treatment for one of the two durations, ones who will be randomly assigned to shorter duration (5 day) will receive zinc for the first 5 days and then placebo for the rest of the days to complete 10 days intake.
- Conditions
- Acute Watery Diarrhoea
- Being tested
- ZINC
- Keywords
- ZINC SUPPLEMENTATION, ACUTE DIARRHOEA, UNDER FIVE CHILDREN, RURAL BANGLADESH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZINCDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment
Assess the acceptability of zinc therapy during diarrhoea in young children.
Secondary outcomes (2)
Compare the duration of current episode in two groups receiving 5 d vs 10 d zinc.
Compare the proportion of children developing prolonged (>10 d) or persistent diarrheoa (>14 d).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startFeb 2005
- Primary completionMay 2006
- Study completionMay 2006
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 Acute Watery DiarrhoeaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Investigators
- Dewan S Alam, PhD, Principal investigator, ICDDR,B: Centre for Health and Population Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325247
- Sponsor's protocol ID
- 2004-018
- Status last verified
- May 2006
- First submitted
- 11 May 2006
- Last updated
- 12 Jul 2011
- Results posted
- No
Publications
Alam DS, Yunus M, El Arifeen S, Chowdury HR, Larson CP, Sack DA, Baqui AH, Black RE. Zinc treatment for 5 or 10 days is equally efficacious in preventing diarrhea in the subsequent 3 months among Bangladeshi children. J Nutr. 2011 Feb;141(2):312-5. doi: 10.3945/jn.110.120857. Epub 2010 Dec 8.
PubMed 21147907
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Short Course Zinc Therapy (5 vs 10 d) With 20 mg Elemental Zinc Daily in the Treatment of Acute Diarrhoea: A Double-blind Individually Randomized Controlled Community Trial.
- ClinicalTrials.gov ID
- NCT00325247
- Acronym / sponsor ID
- 2004-018
- Conditions
- Acute Watery Diarrhoea
- Keywords
- ZINC SUPPLEMENTATION, ACUTE DIARRHOEA, UNDER FIVE CHILDREN, RURAL BANGLADESH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,050 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 12 May 2006 (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.
Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc.
The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea.
This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area.
The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure.
Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.
Detailed description
The proposed study will use a prospective, double-blind, randomized design in which all study children with diarrhoea will receive zinc treatment for the first 5 days and then they will receive either zinc or a placebo for the second 5 days of the 10 day course according to random allocation to evaluate the efficacy of shorter course of zinc treatment (5 days vs 10 days) during diarrhoea in children less than 5 years of age. Children with diarrhoea will be detected through routine daily surveillance by trained Female Field Worker (FFW) in the study area and will be enrolled into the study soon after detection and the informed consent of the parent is obtained. Zinc will be administered daily by FFWs as 20 mg elemental zinc as single dose for 5 or 10 days. Dispersible zinc tablets in blister pack produced by Nutriset® used in the national zinc scaling up project will be used for the study. The placebo will also be dispersible tablets identical and undistinguishable from zinc tablet in terms of appearance, colour, taste and flavour will be obtained from the same manufacturer. The first episode of a child will be treated as part of this study although children will be encouraged to take zinc if s/he develops diarrhoea during the study period. The dose is about double the Recommended Daily Allowance (RDA) for the children which has been chosen considering the poor zinc status of the children to be included and replenishment of possible loss of zinc during diarrhoeal episode and also to be consistent with the current recommendation in the zinc scaling up initiative. Outcome will be assessed daily during routine visit using a precoded questionnaire. Although all the children will receive zinc treatment for one of the two durations, ones who will be randomly assigned to shorter duration (5 day) will receive zinc for the first 5 days and then placebo for the rest of the days to complete 10 days intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children less than 5 years with acute watery diarrhoea less than 48 h of duration
- No medication received other than ORS or home solution
- Absence of complication or co-morbidities.
- Absence of severe dehydration
Key exclusion criteria (6 listed)
- Age greater than 5 years
- Diarrhoea more than 48 h duration
- Unable to eat or drink
- Already received multiple treatment including zinc
- Presence of co-morbidities
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 | Drug | – |
Primary outcome
Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment
Assess the acceptability of zinc therapy during diarrhoea in young children.
2 secondary outcomes
Compare the duration of current episode in two groups receiving 5 d vs 10 d zinc.
Compare the proportion of children developing prolonged (>10 d) or persistent diarrheoa (>14 d).
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 12 Jul 2011.
- Derived from this study: PubMed 21147907Alam DS, Yunus M, El Arifeen S, Chowdury HR, Larson CP, Sack DA, Baqui AH, Black RE. Zinc treatment for 5 or 10 days is equally efficacious in preventing diarrhea in the subsequent 3 months among Bangladeshi children. J Nutr. 2011 Feb;141(2):312-5. doi: 10.3945/jn.110.120857. Epub 2010 Dec 8.
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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.
Dewan S Alam, PhD principal investigator
ICDDR,B: Centre for Health and Population Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZINC in people with Acute Watery Diarrhoea, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 6 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 12 Jul 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 Bangladesh. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment. 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?
On the ClinicalTrials.gov record for NCT00325247, 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 12 Jul 2011.