Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months
NCT ID: NCT02280330
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
396 participants
INTERVENTIONAL
2014-11-30
2015-03-31
Brief Summary
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Detailed Description
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WHO estimated that two billion people worldwide, including 1/3 of school-age children (de Benoist et al. cited by Zimmerman, 2011) suffer from iodine deficiency. Evidence is lacking as to whether schoolchildren are good proxy for other groups such as young children (Sullivam, 2010). In the Philippines, no data exists on the iodine status of preschool children.
One recent approach for improving the vitamin and mineral status of the population is the use of micronutrient powder which contains 15 vitamins and minerals including iodine (HF-TAG 2011). While the MNP has been found effective to improve iron status, its effectiveness in improving iodine status has yet to be studied. Further, the provision of iodine through MNPs as well as the combined impact of salt iodization and use of MNPs, warrant investigation. It would also be of interest to generate data on the knowledge, attitude and practices of their parents or other caregiver who primarily take care of planning and provision of food for the family on iodine, iodized salt and MNP.
Day care centers (DCC) are chosen as the site of the study considering their conduct of 120-days supplementary feeding yearly and the organized structure presents a better compliance and easier monitoring of use. Further, the day care pupils, more or less, represent the preschoolers in the barangay and there may be commonality (homogeneity) of the children in age and other characteristics.
In the absence of guidelines for MNP use among children 24 months or older, the existing guidelines such as 60 sachets in 6 months as stipulated in DOH AO 2011-0303 will be followed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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MNP group
The MNP group will receive 60 sachets of MNP in a period of 6 months or 10 sachets per month equivalent to 3-4 sachets in a week.
MNP group
MNP contains 15 vitamins an minerals, including Vitamin ADEC, B1, B2, B6, B12, Niacin, Folic Acid, Iron, Zine, Copper, Selenium and Iodine. There is 90 microgram of iodine per sachet of one gram of MNP.
Placebo group
The placebo group will receive 60 sachets of placebo (with same characteristics) as the MNP or 10 sachets per month equivalent to 3-4 sachets in a week.
Placebo group
The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.
Interventions
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MNP group
MNP contains 15 vitamins an minerals, including Vitamin ADEC, B1, B2, B6, B12, Niacin, Folic Acid, Iron, Zine, Copper, Selenium and Iodine. There is 90 microgram of iodine per sachet of one gram of MNP.
Placebo group
The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* with obvious clinical problem like goiter, congenital heart disease
* with plans of transferring residence outside the municipality within the next 6 months
4 Years
6 Years
ALL
Yes
Sponsors
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Nutrition Center of the Philippines
OTHER
Responsible Party
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Principal Investigators
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Imelda O Degay
Role: PRINCIPAL_INVESTIGATOR
University of the Philippines Los Banos
Locations
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La Trinidad Benguet Day Care Centers
La Trinidad, Benguet, Philippines
Countries
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Other Identifiers
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NCP-RPU-2014-0001
Identifier Type: -
Identifier Source: org_study_id