DiarrheaPhase 3NCT00530829
Impact of Home Zinc Treatment for Acute Diarrhea in Children
A Phase 3 study testing zinc in people with Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Kenya.
Trial summary
Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. Read more about this study
- Who is it for?
- Ages 2 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2007to Apr 2009
- 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 2 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children 2 to 59 months of age in households within 33 selected villages
Who cannot join
- Children under 2 months of age will not be eligible for enrollment, until they reach 2 months of age as the role of zinc has not been well-studied in neonates. Children of parents who do not give written informed consent for their participation will not be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness and Preventive Impact of Home Zinc Treatment for Acute Diarrhea in Children: A Cluster-randomized Field Trial in Rural Western Kenya
Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied.
Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year.
Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.
- Conditions
- Diarrhea
- Being tested
- zinc
- Keywords
- diarrhea, zinc, oral rehydration therapy
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zincDrug
10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mothers recieve a blister pack of zinc tablets in home every two months for use when child in home under 5 years has diarrhea. ORS satchets also given. Instructions on when and how to use zinc and ORS and when to take child in clinic are given by community health worker. Zinc will also be given in clinic if child visits clinic with diarrhea and has not yet started zinc at home. Receives: Drug: zinc |
| 2 | Active comparator | Mothers recieve ORS satchets at home every two months for use when child in home under 5 years has diarrhea. Instructions on when and how to use ORS and when to take child in clinic are given by community health worker. Zinc will be given in clinic if child visits clinic with diarrhea. Receives: Drug: zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only
Measured: One year
Secondary outcomes (1)
To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic decreases the likelihood of recurrent diarrhea episodes, acute respiratory infections, and antimicrobial use
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionApr 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Kenya Medical Research Institute, International Centre for Diarrhoeal Disease Research, Bangladesh
- Investigators
- Daniel R Feikin, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530829
- Sponsor's protocol ID
- CDC-NCPDCID-4678
- Status last verified
- Mar 2010
- First submitted
- 17 Sep 2007
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Feikin DR, Bigogo G, Audi A, Pals SL, Aol G, Mbakaya C, Williamson J, Breiman RF, Larson CP. Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya. PLoS One. 2014 May 16;9(5):e94436. doi: 10.1371/journal.pone.0094436. eCollection 2014.
PubMed 24835009
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Preventive Impact of Home Zinc Treatment for Acute Diarrhea in Children: A Cluster-randomized Field Trial in Rural Western Kenya
- ClinicalTrials.gov ID
- NCT00530829
- Acronym / sponsor ID
- CDC-NCPDCID-4678
- Conditions
- Diarrhea
- Keywords
- diarrhea, zinc, oral rehydration therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Kenya Medical Research Institute, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Sep 2007 (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.
Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied.
Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year.
Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: zincMothers recieve a blister pack of zinc tablets in home every two months for use when child in home under 5 years has diarrhea. ORS satchets also given. Instructions on when and how to use zinc and ORS and when to take child in clinic are given by community health worker. Zinc will also be given in clinic if child visits clinic with diarrhea and has not yet started zinc at home. |
| 2 | Active comparator | Drug: zincMothers recieve ORS satchets at home every two months for use when child in home under 5 years has diarrhea. Instructions on when and how to use ORS and when to take child in clinic are given by community health worker. Zinc will be given in clinic if child visits clinic with diarrhea. |
Who may qualify
- Ages
- 2 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children 2 to 59 months of age in households within 33 selected villages
Key exclusion criteria (1 listed)
- Children under 2 months of age will not be eligible for enrollment, until they reach 2 months of age as the role of zinc has not been well-studied in neonates. Children of parents who do not give written informed consent for their participation will not be enrolled.
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 |
|---|---|---|
| zinc10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months | Drug | 1, 2 |
Primary outcome
To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only
Time frame: One year
1 secondary outcome
To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic decreases the likelihood of recurrent diarrhea episodes, acute respiratory infections, and antimicrobial use
Time frame: one 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 9 Mar 2010.
- Derived from this study: PubMed 24835009Feikin DR, Bigogo G, Audi A, Pals SL, Aol G, Mbakaya C, Williamson J, Breiman RF, Larson CP. Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya. PLoS One. 2014 May 16;9(5):e94436. doi: 10.1371/journal.pone.0094436. eCollection 2014.
- Document WHO/FCH/CAH/04.7Link provided by the sponsor.
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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.
Daniel R Feikin, MD principal investigator
Centers for Disease Control and Prevention
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 Diarrhea, run by Centers for Disease Control and Prevention at 1 site in Kenya.
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 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 9 Mar 2010. 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 Kenya. 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?
To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only (time frame: One year). 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 NCT00530829, 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 9 Mar 2010.