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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: PACTR
Last refreshed on: 29 May 2023
Main ID:  PACTR201711002737120
Date of registration: 31/10/2017
Prospective Registration: No
Primary sponsor: MUHAS
Public title: Zinc Adherence: A Follow-up Study of Under-fives with Acute Watery Diarrhoea Using Mobile Phones ¿ A Randomised Controlled Trial
Scientific title: Zinc Adherence: A Follow-up Study of Under-fives with Acute Watery Diarrhoea Using Mobile Phones ¿ A Randomised Controlled Trial
Date of first enrolment: 01/12/2016
Target sample size: 196
Recruitment status: Complete
URL:  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2737
Study type:  Interventional
Study design:  Parallel: different groups receive different interventions at same time during study,Randomised,Block randomization in a 1:1 ratio with block size of 4, using StatsDirect software,Allocation was not specifically concealed, but I enrolled patients, and then later checked the randomization list, which was at a location away from the study site  
Phase:  Not Applicable
Countries of recruitment
Tanzania
Contacts
Name: Fatimah Zahra    Karim
Address:  76 Sambwisi st. Box 21206 Dar es Salaam Tanzania
Telephone: +255 715 436 487
Email: fzahrakarim@gmail.com
Affiliation:  Master's student
Name: Fatimah Zahra    Karim
Address:  76 Sambwisi st. Box 21206 Dar es Salaam Tanzania
Telephone: +255 715 436 487
Email: fzahrakarim@gmail.com
Affiliation:  Master's student
Key inclusion & exclusion criteria
Inclusion criteria: Children under age of 5 years with:
Acute watery diarrhoea
No dehydration
Prescribed Ped Zinc on the day of enrolment

and
Parent/guardian owned a mobile phone

Exclusion criteria: Any comorbidity requiring admission
Already on day 2 or more of Zinc


Age minimum: 0 Day(s)
Age maximum: 5 Year(s)
Gender: Both
Health Condition(s) or Problem(s) studied
Digestive System
Acute Watery Diarrhoea

Digestive System
Acute Watery Diarrhoea
Intervention(s)
mobile follow up
None
Primary Outcome(s)
10-day adherence to zinc sulphate prescribed
Secondary Outcome(s)
Dependability of mHealth
Acceptability of mHealth
Clinic attendance for follow-up visit
Secondary ID(s)
Source(s) of Monetary Support
Global Pediatric Infectious Disease training grant-MUHAS-from the NIH
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 27/10/2016
Contact:
MUHAS IRB
Results
Results available:
Date Posted:
Date Completed:
URL:
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