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Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

This study has been completed.
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01695304
First received: September 26, 2012
Last updated: February 1, 2017
Last verified: September 2015
  Purpose
The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very young children are given drinking water or water is used in reconstitution of their food. We hypothesize that ceramic water filters will remove Cryptosporidium from drinking water reducing infection in infants.

Condition Intervention
Cryptosporidium; Diarrhea Cryptosporidiosis Communicable Diseases Diarrheal Disease Other: Ceramic water filter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Masking Description:
This is an intervention trial of ceramic water filters, and as such cannot be masked. The intervention participants received the CWFs during the trial and the control group after the trial was over.
Primary Purpose: Prevention
Official Title: Pilot Intervention Trial of Ceramic Water Filters to Reduce the Burden of Cryptosporidium in Household Drinking Water in Rural Kenya.

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Longitudinal Diarrhea Prevalence [ Time Frame: 6 months ]
    The primary outcome measure is the longitudinal prevalence of diarrheal disease.

  • Health Facility Visits for Diarrheal Disease [ Time Frame: 6 months ]
    incidence rate of health facility visits for diarrheal disease per 100 person-week of observation


Enrollment: 227
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Arm
Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
Other: Ceramic water filter
In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
Other Name: Cera Maji ceramic water filter
No Intervention: Control Arm
Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.

Detailed Description:
Diarrhea is a major cause of illness among children in Africa. Cryptosporidium is a protozoan waterborne diarrheal pathogen resistant to chlorine. Ceramic filters are effective at improving drinking water quality, including removal of protozoa. In a recent preliminary analysis of >22,000 children <5 years enrolled in the Global Enterics Multi-Center Study (GEMS) case-control study of moderate-to-severe diarrhea, Cryptosporidium was identified as a leading cause of diarrhea in infants across all four participating African sites. This pilot is the first Cryptosporidium specific intervention trial of household ceramic water filters to reduce the burden of cryptosporidiosis acquired through drinking water in rural Kenya.
  Eligibility

Ages Eligible for Study:   4 Months to 10 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Children 4-10 months old living in selected villages in the Asembo Health and Demographic Surveillance System (HDSS) study area in Kenya whose primary caretakers consent on their behalf to be visited weekly for 6 months to carry out weekly illness surveillance, and have a follow up home visit one year after initial enrollment into the trial. The household in which the child resides must be a consenting participant in the HDSS. As the children included in the trial are infants, the child's primary caretaker will be invited to participate and be administered questionnaires. Random selection will be at the compound level. Only one household per compound will be eligible for selection.

Exclusion Criteria:

Children 4-10 months old whose households are not active consenting participants in the HDSS will not be eligible for inclusion. Only the subset of children 4-10 months old who are randomly selected in the sample will be eligible for participation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695304

Locations
Kenya
Kemri/Cdc
Kisumu, Kenya
Sponsors and Collaborators
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Investigators
Principal Investigator: Eric Mintz, MD, MPH Centers for Disease Control and Prevention
  More Information

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01695304     History of Changes
Other Study ID Numbers: CDC-NCEZID-6369
CDCEID10A.1 ( Other Identifier: Centers for Disease Control and Prevention )
2439 ( Other Identifier: Kenya Medical Research Institute )
Study First Received: September 26, 2012
Results First Received: September 28, 2015
Last Updated: February 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No PII will be shared with any researcher. It is possible that researchers may request access to the clean de-identified data once closed out for all aspects of the work.

Keywords provided by Centers for Disease Control and Prevention:
Cryptosporidiosis
Waterborne disease
Diarrheal disease
Ceramic water filters
infants
young children
drinking water
Kenya

Additional relevant MeSH terms:
Diarrhea
Cryptosporidiosis
Communicable Diseases
Infection
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections, Animal
Parasitic Diseases, Animal
Coccidiosis
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 16, 2017