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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
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Prevention
Conditions: Cryptosporidium; Diarrhea
Cryptosporidiosis
Communicable Diseases
Diarrheal Disease
Intervention: Other: Ceramic water filter

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intervention Arm

Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.

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.

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.

Participant Flow:   Overall Study
    Intervention Arm   Control Arm
STARTED   120   120 
COMPLETED   120 [1]   120 [2] 
NOT COMPLETED   0   0 
[1] 2 deaths & 1 drop out in the intervention group, contributed some information over the 26 weeks
[2] 3 deaths & 2 drop out in the intervention group, contributed some information over the 26 weeks



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Arm

Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.

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.

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.
Total Total of all reporting groups

Baseline Measures
   Intervention Arm   Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   120   240 
Age 
[Units: Months]
Median (Full Range)
 7 
 (4 to 10) 
 8 
 (4 to 10) 
 7.5 
 (4 to 10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      66  55.0%      62  51.7%      128  53.3% 
Male      54  45.0%      58  48.3%      112  46.7% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Luo ethnic group   120   120   240 
Region of Enrollment 
[Units: Participants]
     
Kenya   120   120   240 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Longitudinal Diarrhea Prevalence   [ Time Frame: 6 months ]

2.  Primary:   Health Facility Visits for Diarrheal Disease   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ciara O'Reilly, PhD
Organization: Centers for Disease Control and Prevention
phone: 404-639-1953
e-mail: bwf1@cdc.gov



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