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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT02196337 |
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Date of registration:
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02/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Salt Iodization: Meeting the Needs of Pregnancy, Lactation and Infancy
SIMPLIFY |
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Scientific title:
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Salt Iodization and the 1st 1000 Days: Does a USI Program Cover the Iodine Requirement of Pregnant and Lactating Women and Infants? |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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8000 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02196337 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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China
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Croatia
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Ghana
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Philippines
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Switzerland
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Contacts
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Name:
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Maria Andersson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zurich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- living at study area for at least 6 months
- generally healthy
- no chronic medication
- no history of thyroid disease in the family
- no use of iodine containing dietary supplements during the last 6 months
- no use of iodine containing disinfectants for the last 6 months
- no use of X-ray / CT contrast agent or iodine containing medication within the last
year
- in addition for women of reproductive age, pregnant women and breastfeeding women:
age between 18 and 44 years old
- in addition for pregnant women: healthy pregnancy, singleton pregnancy (no twins or
multiple pregnancy)
- in addition for breastfeeding women and breastfed infants: healthy pregnancy,
singleton pregnancy (no twins or multiple pregnancy), baby born at full-term (in
pregnancy week 38 to 42), the baby had normal birth weight (= 2500 g), baby not older
than 6 months, baby currently completely breastfed (except for water, tea and juices)
- in addition for toddlers: between 6 and 24 months old
Age minimum:
N/A
Age maximum:
44 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Iodine Deficiency
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Primary Outcome(s)
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Urinary iodine concentration (µg/L)
[Time Frame: 1 day]
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Secondary Outcome(s)
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Thyroglobulin (µg/L)
[Time Frame: 1 day]
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Breast milk iodine concentration (µg/L)
[Time Frame: 1 day]
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Secondary ID(s)
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EK 2013-N-82
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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