DiarrheaPhase 1NCT00278681
Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
A Phase 1 study testing Zinc and ORS in people with Diarrhea and Hospitalization, run by Society for Applied Studies at 1 site in India.
Trial summary
Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and child mortality as it could reach the most vulnerable children in a community and reduce severity of not only diarrhea but also of associated infections. It might also potentially reduce antibiotic use. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Diarrhea, Hospitalization
- What is being tested?
- Zinc and ORS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,364 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2003to Aug 2004
- Phase
- Phase 1
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 month to 5 years with diarrhea
Who cannot join
- Illness requiring hospitalization (referral)
Trial locations and contacts
1 site in 1 country.
India1 site
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110017
About this study
Official title: An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhoea in a Primary Health Care Setting. Phase I
Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and child mortality as it could reach the most vulnerable children in a community and reduce severity of not only diarrhea but also of associated infections. It might also potentially reduce antibiotic use.
We conducted a pilot study prior to conducting a community based controlled effectiveness trial to assess whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, reduces visits to health care providers, antibiotic and other drug use, and increases ORS use during diarrhea.
Read the detailed description
The pilot study was conducted in a primary health centre (population ~33000) in Faridabad district of the state of Haryana in India. Formative research identified perceptions of caregivers regarding childhood diarrhea, causation and management, care seeking sources and caregivers expectations from healthcare providers. Caregivers in households with children under 5 years old were interviewed in a cross sectional survey to ascertain family characteristics, ORS prescription and use rates, drug prescription rates by healthcare providers and other variables of interest.
In partnership with the local government, channels for distribution of zinc and ORS packets were defined. The channels included physicians (at PHC and private practitioners), auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs)of the Integrated Child Development Services (ICDS) scheme. Recommendations were developed and translated into local vernacular. A poster, which incorporated the recommendations and pictures of zinc strip and ORS packets, was designed. These posters were put up at different places in the study area. All channels were trained and provided with the supplies of zinc strips and ORS packets except the private practitioners who received only zinc strips and advised caregivers to take ORS packets from government channels. Effectiveness of this pilot program was assessed through 2 cross sectional surveys, 3 and 6 months post training.
The cross sectional surveys revealed that the prescription of syrups, tablets, powders and injections during diarrhea and cost of treatment decreased significantly. Prescription and use of ORS increased markedly. Zinc tablets were prescribed and used in about half the episodes 6 months after start of intervention. It was feasible to train various government and community channels to promote zinc as treatment of acute diarrhea through the primary health care system.
- Conditions
- Diarrhea, Hospitalization
- Being tested
- Zinc and ORS
- Keywords
- zinc, diarrhea, hospitalization, programme
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc and ORSDrug
One strip containing 14 dispersible zinc tablets (20 mg each) along with 2 ORS packets were prescribed to all children aged 1 month to 5 years visiting that channel with diarrhea.
Infants aged less than 6 months were advised half a zinc tablet in a teaspoonful of breast milk; older children were advised 1 tablet in breast milk or clean water.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Zinc and ORS Receives: Drug: Zinc and ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Reduction in antibiotics and other drugs use during diarrheal illnesses
Measured: August 2003 to August 2004
- Increase in ORS use during diarrhea
Measured: August 2003 to August 2004
- Reduction in hospitalizations; all cause and diarrhea related
Measured: August 2003 to August 2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startAug 2003
- Primary completionAug 2004
- Study completionAug 2004
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, World Health Organization
- Investigators
- Nita Bhandari, PhD, Principal investigator, Society for Applied Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278681
- Sponsor's protocol ID
- HRN-A-96-90006-00
- Other IDs
- 77955
- Status last verified
- Jul 2008
- First submitted
- 13 Jan 2006
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhandari N, Mazumder S, Taneja S, Dube B, Black RE, Fontaine O, Mahalanabis D, Bhan MK. A pilot test of the addition of zinc to the current case management package of diarrhea in a primary health care setting. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):685-7. doi: 10.1097/01.mpg.0000182799.69675.92.
PubMed 16254536
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhoea in a Primary Health Care Setting. Phase I
- ClinicalTrials.gov ID
- NCT00278681
- Acronym / sponsor ID
- HRN-A-96-90006-00
- Conditions
- Diarrhea, Hospitalization
- Keywords
- zinc, diarrhea, hospitalization, programme
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,364 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- Johns Hopkins University, World Health Organization
- Study start
- Aug 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 18 Jan 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.
Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and child mortality as it could reach the most vulnerable children in a community and reduce severity of not only diarrhea but also of associated infections. It might also potentially reduce antibiotic use.
We conducted a pilot study prior to conducting a community based controlled effectiveness trial to assess whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, reduces visits to health care providers, antibiotic and other drug use, and increases ORS use during diarrhea.
Detailed description
The pilot study was conducted in a primary health centre (population ~33000) in Faridabad district of the state of Haryana in India. Formative research identified perceptions of caregivers regarding childhood diarrhea, causation and management, care seeking sources and caregivers expectations from healthcare providers. Caregivers in households with children under 5 years old were interviewed in a cross sectional survey to ascertain family characteristics, ORS prescription and use rates, drug prescription rates by healthcare providers and other variables of interest.
In partnership with the local government, channels for distribution of zinc and ORS packets were defined. The channels included physicians (at PHC and private practitioners), auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs)of the Integrated Child Development Services (ICDS) scheme. Recommendations were developed and translated into local vernacular. A poster, which incorporated the recommendations and pictures of zinc strip and ORS packets, was designed. These posters were put up at different places in the study area. All channels were trained and provided with the supplies of zinc strips and ORS packets except the private practitioners who received only zinc strips and advised caregivers to take ORS packets from government channels. Effectiveness of this pilot program was assessed through 2 cross sectional surveys, 3 and 6 months post training.
The cross sectional surveys revealed that the prescription of syrups, tablets, powders and injections during diarrhea and cost of treatment decreased significantly. Prescription and use of ORS increased markedly. Zinc tablets were prescribed and used in about half the episodes 6 months after start of intervention. It was feasible to train various government and community channels to promote zinc as treatment of acute diarrhea through the primary health care system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Zinc and ORSZinc and ORS |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 1 month to 5 years with diarrhea
Key exclusion criteria (1 listed)
- Illness requiring hospitalization (referral)
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 and ORSOne strip containing 14 dispersible zinc tablets (20 mg each) along with 2 ORS packets were prescribed to all children aged 1 month to 5 years visiting that channel with diarrhea. Infants aged less than 6 months were advised half a zinc tablet in a teaspoonful of breast milk; older children were advised 1 tablet in breast milk or clean water. | Drug | I |
Primary outcome
- Reduction in antibiotics and other drugs use during diarrheal illnesses
Time frame: August 2003 to August 2004
- Increase in ORS use during diarrhea
Time frame: August 2003 to August 2004
- Reduction in hospitalizations; all cause and diarrhea related
Time frame: August 2003 to August 2004
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 2 Jul 2008.
- Results publication: PubMed 16254536Bhandari N, Mazumder S, Taneja S, Dube B, Black RE, Fontaine O, Mahalanabis D, Bhan MK. A pilot test of the addition of zinc to the current case management package of diarrhea in a primary health care setting. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):685-7. doi: 10.1097/01.mpg.0000182799.69675.92.
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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.
Nita Bhandari, PhD principal investigator
Society for Applied Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zinc and ORS in people with Diarrhea and Hospitalization, run by Society for Applied Studies at 1 site in India.
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 2 Jul 2008. 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 India. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
- Reduction in antibiotics and other drugs use during diarrheal illnesses (time frame: August 2003 to August 2004). The study lists 3 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 NCT00278681, 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 2 Jul 2008.