Diarrhea ToddlerNCT06444633

The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea

A study testing Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc in people with Diarrhea Toddler, run by RAND at 1 site in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. Read more about this study

Who is it for?: Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for: Diarrhea Toddler
What is being tested?: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102,650 participants
Where: 1 siteNigeria
Study dates: 4 Sep 2024to 14 Aug 2026
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 15 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

At least 15 years old
Has at least one child under 5 at baseline
Proficiency in English or Hausa

Who cannot join

Living in a temporary home (nomadic population)
Does not speak English or Hausa
Unable to give informed consent

Trial locations and contacts

1 site in 1 country.

Nigeria1 site

Clinton Health Access Initiative
Abuja

Other trials in Nigeria

About this study

Official title: The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea: a Cluster Randomized Controlled Trial in Bauchi, Nigeria

RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?
RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?
RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?

All wards in Bauchi state will be randomly assigned to one of two groups:

treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.

A total of 1,732 enumeration areas (EAs) will be sampled across all wards for the study period. Within each EA, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.

Conditions: Diarrhea Toddler
Being tested: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
Keywords: Oral Rehydration Salts, Child Diarrhea, Zinc

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+ZincBehavioural
The intervention will involve the following: 1) The communities will be sensitized on the importance of ORS and Zinc use for the treatment of child diarrhea, by the Clinton Health Access Initiative (CHAI). 2) Campaigners recruited by CHAI will visit each household in their catchment area that contain at child under 5 years old. 3) During the distribution visits, the campaigners will train caregivers on the dangers of diarrhea and the importance of ORS and zinc use, among other things (including how to prepare, use, and store ORS/zinc, benefits of the treatments, recommended health behaviors such as seeking care, and encouraging basic handwashing and hygiene practices). The caregivers will also receive a flyer describing the same information in their local language, for future reference. 4) Campaigners will then distribute two ORS and zinc co-packs (each co-pack contains two sachets of ORS and 10 tablets of zinc) for free for each child under the age of five in the household.

Study groups in NCT06444633
Study group	Role	What they receive
Delayed-start control	No intervention	Wards randomly assigned to this arm will not receive any intervention until after endline data collection in completed. During the study period, the caregivers in this group will have standard access to ORS and zinc at local health facilities and pharmacies. Some community health workers in control villages could make household visits; however, any delivery of ORS or zinc in the control group is not expected as community health workers are generally not the source of diarrhea treatment.
Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc	Experimental	Wards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section Receives: Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc

What is being measured

The primary outcome is the main question the study is designed to answer.

ORS Use (cases in last 4 weeks)
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Measured: 1-6 months post intervention
ORS Use (cases in last 4 weeks)
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Measured: 1-12 months post intervention
ORS Use (cases in last 4 weeks)
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Measured: Each month from 1-12 months post intervention

Secondary outcomes (11)

Zinc + ORS use
Self-reported Zinc + ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Antibiotic use
Self-reported antibiotic use for a case of child diarrhea that occurred within the last 4 weeks.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Zinc use alone
Self-reported Zinc use for a case of child diarrhea that occurred within the last 4 weeks.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Time to ORS initiation
Binary and count variables; binary coded to 1 if caregiver started treatment on the same day the diarrhea began; count variable truncated to 7 days.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Exposure to unsafe drinking water
Self-reported use of untreated water to prepare ORS for treating diarrhea experienced by a child who is exclusively breastfed.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Willingness to purchase new ORS packets
Self-reported use of ORS, seeking care, and purchase of ORS among households that experienced at least twice as many diarrhea cases as the number of children under 5.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Child mortality; all cause and from diarrhea
Self-reported mortality (all cause and diarrhea) of children under 5 since intervention
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Hospitalization from diarrhea
Self-reported hospitalization (all cause and diarrhea) of children under 5 since intervention
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Number of diarrhea episodes
Count of episodes of diarrhea experienced by children who had at least one case of diarrhea since intervention.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Care seeking outside the home
Binary indicator, coded to 1 if caregiver sought care from each type of provider.
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Wastage of ORS and zinc packets
Binary indicator, coded to 1 for each type of wastage (co-packs being lost, co-packs being stolen, co-packs used for non-diarrhea reasons, co-packs given away)
Measured: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 202414 Aug 2026

First posted5 Jun 2024
Study start4 Sep 2024
Primary completion14 Aug 2026
Study completion14 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diarrhea ToddlerStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study is a parallel, cluster randomized controlled trial, randomizing administrative wards in Bauchi, Nigeria to treatment (receiving pre-emptive, free ORS+Zinc co-packs (2 nos) per child under 5 to households, along with information about proper use of ORS and Zinc for treating child diarrhea) or delayed-start control (receiving intervention after the end of the study period).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 102,650 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06444633
Sponsor's protocol ID: HCAAD201
Status last verified: Sep 2026
First submitted: 24 May 2024
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified data will be shared in a public repository at the end of the study.

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea: a Cluster Randomized Controlled Trial in Bauchi, Nigeria
ClinicalTrials.gov ID: NCT06444633
Acronym / sponsor ID: HCAAD201
Conditions: Diarrhea Toddler
Keywords: Oral Rehydration Salts, Child Diarrhea, Zinc
Study type: Interventional
Recruitment status: Completed
Enrolment: 102,650 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Clinton Health Access Initiative, Nigeria, Innovations for Poverty Action
Study start: 4 Sep 2024 (actual)
Primary completion: 14 Aug 2026 (actual)
Study completion: 14 Aug 2026 (actual)
First posted: 5 Jun 2024 (actual)
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.

RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?
RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?
RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?

All wards in Bauchi state will be randomly assigned to one of two groups:

treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The study is a parallel, cluster randomized controlled trial, randomizing administrative wards in Bauchi, Nigeria to treatment (receiving pre-emptive, free ORS+Zinc co-packs (2 nos) per child under 5 to households, along with information about proper use of ORS and Zinc for treating child diarrhea) or delayed-start control (receiving intervention after the end of the study period).

Arm	Type	Receives
Delayed-start control	No intervention	–Wards randomly assigned to this arm will not receive any intervention until after endline data collection in completed. During the study period, the caregivers in this group will have standard access to ORS and zinc at local health facilities and pharmacies. Some community health workers in control villages could make household visits; however, any delivery of ORS or zinc in the control group is not expected as community health workers are generally not the source of diarrhea treatment.
Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc	Experimental	Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+ZincWards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

At least 15 years old
Has at least one child under 5 at baseline
Proficiency in English or Hausa

Key exclusion criteria (3 listed)

Living in a temporary home (nomadic population)
Does not speak English or Hausa
Unable to give informed consent

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
Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+ZincThe intervention will involve the following: 1) The communities will be sensitized on the importance of ORS and Zinc use for the treatment of child diarrhea, by the Clinton Health Access Initiative (CHAI). 2) Campaigners recruited by CHAI will visit each household in their catchment area that contain at child under 5 years old. 3) During the distribution visits, the campaigners will train caregivers on the dangers of diarrhea and the importance of ORS and zinc use, among other things (including how to prepare, use, and store ORS/zinc, benefits of the treatments, recommended health behaviors such as seeking care, and encouraging basic handwashing and hygiene practices). The caregivers will also receive a flyer describing the same information in their local language, for future reference. 4) Campaigners will then distribute two ORS and zinc co-packs (each co-pack contains two sachets of ORS and 10 tablets of zinc) for free for each child under the age of five in the household.	Behavioural	Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc

Primary outcome

ORS Use (cases in last 4 weeks)
Time frame: 1-6 months post intervention
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
ORS Use (cases in last 4 weeks)
Time frame: 1-12 months post intervention
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
ORS Use (cases in last 4 weeks)
Time frame: Each month from 1-12 months post intervention
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.

11 secondary outcomes

Zinc + ORS use
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Antibiotic use
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Zinc use alone
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Time to ORS initiation
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Exposure to unsafe drinking water
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Willingness to purchase new ORS packets
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Child mortality; all cause and from diarrhea
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Hospitalization from diarrhea
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Number of diarrhea episodes
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Care seeking outside the home
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Wastage of ORS and zinc packets
Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

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 Sep 2026.
Individual participant dataSharing planned: Yes. Deidentified data will be shared in a public repository at the end of the study.

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.

Zachary Wagner, Ph.D. principal investigator

RAND

Stephanie Bonds, Ph.D. principal investigator

RAND

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc in people with Diarrhea Toddler, run by RAND at 1 site in Nigeria.

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 3 inclusion and 3 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 Sep 2026. 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 Nigeria. 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?

ORS Use (cases in last 4 weeks) (time frame: 1-6 months post intervention). 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 NCT06444633.

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 Sep 2026.