DiarrheaNCT00278746
Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
A study testing Zinc and ORS and ORS only in people with Diarrhea and Mortality, run by Society for Applied Studies at 1 site in India.
Trial summary
Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Diarrhea, Mortality, Hospitalization
- What is being tested?
- Zinc and ORS and ORS only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,032 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2005to Sep 2006
- 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 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 referral to hospital
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 Diarrhea in a Primary Health Care Setting.
Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.
Read the detailed description
This cluster randomized trial aimed at evaluating in a community based controlled effectiveness trial whether addition of 2RDA zinc as a therapeutic modality to the current case management package for diarrhoea in children aged between 1 month and 5 years, delivered through existing channels at village level, resulted in reduction in care seeking from health care providers, antibiotic and other drug use and increase in ORS use rates.
The intervention was being implemented in 6 PHCs; 3 intervention and 3 control.
Based on the experience of a pilot study and the formative research findings, common sources visited by caregivers for care seeking during morbidity were identified. These sources were selected as channels in partnership with the local government, to distribute zinc strips and ORS packets in intervention sites and only ORS packets in control sites. These channels were physicians (at the PHC and private practitioners), the auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs) of the Integrated Child Development Services (ICDS) Scheme. All the channels were trained and supplies of zinc strips and ORS packets, and ORS packets only were distributed in each pair of PHC in intervention and control sites respectively. Recommendations were developed and translated into local vernacular. A poster, incorporating these recommendations and pictures of zinc strips and ORS packets, was designed and put up at various places in the intervention sites. For outcome measurements, cross sectional surveys were conducted at 6 monthly intervals.
Process evaluation activities, which included observations of different channels and exit interviews with mothers after they had visited a channel were conducted.
In the two groups, zinc was used in 36.5% and 59.8% diarrheal episodes and ORS in 34.8% and 59.2% episodes in the 4 weeks preceding interviews in intervention areas. In control areas, ORS was used in 7.8% and 9.8% episodes. Care seeking for diarrhea, prescription of drugs of unknown identity and antibiotics for diarrhea reduced in intervention communities.
The study demonstrated that an intervention to improve diarrhea management with ORS and zinc is feasible and highly acceptable in rural Indian communities. The resulting health benefits were substantial and accomplished with a reduction in the cost to families for diarrhea treatment from current practices.
- Conditions
- Diarrhea, Mortality, Hospitalization
- Being tested
- Zinc and ORS, ORS only
- Keywords
- zinc, diarrhea, cluster randomization, hospitalization
- 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
Government and private providers and village health workers were trained to prescribe zinc and ORS for use in diarrheal episodes in 1 month to 5 years old children in intervention communities
ORS onlyDrug
Promoted routine management of diarrhea in underfive with ORS
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zinc and ORS were promoted for treatment of diarrhea in underfive children Receives: Drug: Zinc and ORS |
| 2 | Other | Promoted routine management of diarrhea in underfive with ORS Receives: Drug: ORS only |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children
Measured: 20 months (Jan 2005 to Sep 2006)
- Reduction in visits to health care providers for treatment of illness
Measured: 20 months (Jan 2005 to Sep 2006)
- Reduction in drug use; antibiotics and other drugs during diarrheal illnesses
Measured: 20 months (Jan 2005 to Sep 2006)
- Increase in ORS use during diarrhea in the intervention communities.
Measured: 20 months (Jan 2005 to Sep 2006)
Secondary outcomes (1)
- Reduction in all cause hospitalizations
Measured: 20 months (Jan 2005 to Sep 2006)
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 startJan 2005
- Primary completionSep 2006
- Study completionSep 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, India, United Nations Children's Fund, Delhi, World Health Organization
- Investigators
- Nita Bhandari, PhD, Principal investigator, Society for Applied Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278746
- Sponsor's protocol ID
- PR-5268/PID/20/198/2004
- Status last verified
- Jun 2015
- First submitted
- 13 Jan 2006
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhandari N, Mazumder S, Taneja S, Dube B, Agarwal RC, Mahalanabis D, Fontaine O, Black RE, Bhan MK. Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial. Pediatrics. 2008 May;121(5):e1279-85. doi: 10.1542/peds.2007-1939.
PubMed 18450870
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. 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 Diarrhea in a Primary Health Care Setting.
- ClinicalTrials.gov ID
- NCT00278746
- Acronym / sponsor ID
- PR-5268/PID/20/198/2004
- Conditions
- Diarrhea, Mortality, Hospitalization
- Keywords
- zinc, diarrhea, cluster randomization, hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,032 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, India, United Nations Children's Fund, Delhi, World Health Organization
- Study start
- Jan 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (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.
Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.
Detailed description
This cluster randomized trial aimed at evaluating in a community based controlled effectiveness trial whether addition of 2RDA zinc as a therapeutic modality to the current case management package for diarrhoea in children aged between 1 month and 5 years, delivered through existing channels at village level, resulted in reduction in care seeking from health care providers, antibiotic and other drug use and increase in ORS use rates.
The intervention was being implemented in 6 PHCs; 3 intervention and 3 control.
Based on the experience of a pilot study and the formative research findings, common sources visited by caregivers for care seeking during morbidity were identified. These sources were selected as channels in partnership with the local government, to distribute zinc strips and ORS packets in intervention sites and only ORS packets in control sites. These channels were physicians (at the PHC and private practitioners), the auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs) of the Integrated Child Development Services (ICDS) Scheme. All the channels were trained and supplies of zinc strips and ORS packets, and ORS packets only were distributed in each pair of PHC in intervention and control sites respectively. Recommendations were developed and translated into local vernacular. A poster, incorporating these recommendations and pictures of zinc strips and ORS packets, was designed and put up at various places in the intervention sites. For outcome measurements, cross sectional surveys were conducted at 6 monthly intervals.
Process evaluation activities, which included observations of different channels and exit interviews with mothers after they had visited a channel were conducted.
In the two groups, zinc was used in 36.5% and 59.8% diarrheal episodes and ORS in 34.8% and 59.2% episodes in the 4 weeks preceding interviews in intervention areas. In control areas, ORS was used in 7.8% and 9.8% episodes. Care seeking for diarrhea, prescription of drugs of unknown identity and antibiotics for diarrhea reduced in intervention communities.
The study demonstrated that an intervention to improve diarrhea management with ORS and zinc is feasible and highly acceptable in rural Indian communities. The resulting health benefits were substantial and accomplished with a reduction in the cost to families for diarrhea treatment from current practices.
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: Zinc and ORSZinc and ORS were promoted for treatment of diarrhea in underfive children |
| 2 | Other | Drug: ORS onlyPromoted routine management of diarrhea in underfive with 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 referral to hospital
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 ORSGovernment and private providers and village health workers were trained to prescribe zinc and ORS for use in diarrheal episodes in 1 month to 5 years old children in intervention communities | Drug | 1 |
| ORS onlyPromoted routine management of diarrhea in underfive with ORS | Drug | 2 |
Primary outcome
To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children
Time frame: 20 months (Jan 2005 to Sep 2006)
- Reduction in visits to health care providers for treatment of illness
Time frame: 20 months (Jan 2005 to Sep 2006)
- Reduction in drug use; antibiotics and other drugs during diarrheal illnesses
Time frame: 20 months (Jan 2005 to Sep 2006)
- Increase in ORS use during diarrhea in the intervention communities.
Time frame: 20 months (Jan 2005 to Sep 2006)
1 secondary outcome
- Reduction in all cause hospitalizations
Time frame: 20 months (Jan 2005 to Sep 2006)
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 16 Jun 2015.
- Results publication: PubMed 18450870Bhandari N, Mazumder S, Taneja S, Dube B, Agarwal RC, Mahalanabis D, Fontaine O, Black RE, Bhan MK. Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial. Pediatrics. 2008 May;121(5):e1279-85. doi: 10.1542/peds.2007-1939.
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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 study testing Zinc and ORS and ORS only in people with Diarrhea and Mortality, 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 16 Jun 2015. 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.
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 evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children (time frame: 20 months (Jan 2005 to Sep 2006)). The study lists 4 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 NCT00278746, 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 16 Jun 2015.