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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03355222
Date of registration: 09/11/2017
Prospective Registration: Yes
Primary sponsor: University of Saskatchewan
Public title: Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
Scientific title: Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia
Date of first enrolment: January 2, 2018
Target sample size: 270
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03355222
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Ethiopia
Contacts
Name:     Susan Whiting, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Saskatchewan
Key inclusion & exclusion criteria

Inclusion Criteria:

- All women with a child age 6 to 18 months and their child living permanently in the
village

- the woman does not have to be biological mother Exclusion Criteria:

- Exclude families with a child who is known to be allergic to egg

- Exclude families with a child who is diagnosed as malnourished (moderate malnutrition
(MAM) or severe malnutrition (SAM)

- Exclude women who do not live with the child



Age minimum: 6 Months
Age maximum: 18 Months
Gender: All
Health Condition(s) or Problem(s) studied
Hemoglobin
Underweight
Fluorosis, Dental
Stunting
Fluoride Poisoning
Fluorosis; Skeletal
Development; Delayed, Mental
Zinc Deficiency
Intervention(s)
Behavioral: Promotion of chicken eggs
Primary Outcome(s)
Apparent fluoride absorption [Time Frame: 6 months]
Secondary Outcome(s)
Knowledge, attitude and practices (KAP) for egg [Time Frame: 6 and 12 months]
Functional indicators of fluorosis [Time Frame: 6 months]
Linear growth in young children [Time Frame: 6 months and 12 months]
Growth in young children [Time Frame: 6 months and 12 months]
Hemoglobin (Hb) [Time Frame: 6 months and 12 months]
Secondary ID(s)
HU-UoS-EGGSHELL-FLUORIDE
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Hawassa University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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