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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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4 January 2016 |
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Main ID: |
NCT02280330 |
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Date of registration:
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27/10/2014 |
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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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Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months
MNP-CAR |
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Scientific title:
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Iodine Intake & Status of Preschoolers Given Micronutrient Powder for 6 Months |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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396 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02280330 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Imelda O Degay |
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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 the Philippines Los Banos |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- apparently healthy
- permanent resident in the barangay or municipality
- 4-6 years old
- with informed written parental consent
- whose mothers are willing to devote time for the survey
Exclusion Criteria:
- severely underweight
- with obvious clinical problem like goiter, congenital heart disease
- with plans of transferring residence outside the municipality within the next 6
months
Age minimum:
4 Years
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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Iodine Deficiency Disorder
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Hypothyroidism
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Intervention(s)
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Other: Placebo group
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Dietary Supplement: MNP group
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Primary Outcome(s)
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Iodine status based on urinary iodine measures
[Time Frame: 6 months]
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Secondary Outcome(s)
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Levels of iodine intake
[Time Frame: 6 months]
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Likability of a communication material on the knowledge of the mothers/caregivers regarding iodine, iodized salt and micronutrient powder
[Time Frame: 6 months]
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Association of environmental sanitation with iodine intake
[Time Frame: 6 months]
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Association of child characteristics with iodine intake
[Time Frame: 6 months]
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Association of mother/caregiver characteristics with iodine intake
[Time Frame: 6 months]
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Association of household characteristics with iodine intake
[Time Frame: 6 months]
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Change in growth as indicated by anthropometric parameters such as weight for age and height for age
[Time Frame: 6 months]
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Secondary ID(s)
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NCP-RPU-2014-0001
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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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