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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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3 August 2015 |
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Main ID: |
NCT02301520 |
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Date of registration:
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23/11/2014 |
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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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Vitamin D, Iodine, and Lead Levels in Haitian Infants and Children.
Haiti |
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Scientific title:
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Vitamin D Deficiency, Iodine Deficiency and Lead Levels in Haitian Infants and Children. |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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299 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02301520 |
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Study type:
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Observational |
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Study design:
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Observational Model: Ecologic or Community, 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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Haiti
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Contacts
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Name:
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Julia Von Oettingen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Boston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Haitian ethnicity
- Age between nine months and six years
Exclusion Criteria:
- Presence of a chronic medical condition other than malnutrition
- Residence outside of Haiti (i.e. visiting children who usually live abroad).
Age minimum:
9 Months
Age maximum:
6 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Iodine Deficiency
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Rickets
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Vitamin D Deficiency
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Hypothyroidism
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Lead Intoxication
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Primary Outcome(s)
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serum lead levels
[Time Frame: Baseline]
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urinary iodine levels
[Time Frame: Baseline]
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serum 25OHD levels
[Time Frame: Baseline]
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Secondary Outcome(s)
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Determine the accuracy of the POCT device
[Time Frame: Baseline]
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Environmental disruptors of thyroid function
[Time Frame: Baseline]
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Number of children found to have elevated alkaline phosphatase levels
[Time Frame: Baseline]
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Lead intoxication
[Time Frame: Baseline]
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Goiter and abnormal thyroid function tests
[Time Frame: Baseline]
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Dietary and sun exposure effect on vitamin D level
[Time Frame: Baseline]
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Secondary ID(s)
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Haitistudy
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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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