Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months (MNP-CAR)
Primary Purpose
Iodine Deficiency, Iodine Deficiency Disorder, Hypothyroidism
Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
MNP group
Placebo group
Sponsored by
About this trial
This is an interventional supportive care trial for Iodine Deficiency focused on measuring Iodine Deficiency, Micronutrient Powder, Hypothyroidism
Eligibility Criteria
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
Sites / Locations
- La Trinidad Benguet Day Care Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MNP group
Placebo group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Iodine status based on urinary iodine measures
Secondary Outcome Measures
Change in growth as indicated by anthropometric parameters such as weight for age and height for age
Levels of iodine intake
Association of child characteristics with iodine intake
Child characteristics include age, birth order, common illnesses
Association of mother/caregiver characteristics with iodine intake
Mother / Caregiver information includes age, religion, ethnic tribe, educational attainment, occupation and economic role in the family
Association of household characteristics with iodine intake
Household information includes status of residence, length of residence, type of residence, nature of living arrangement, source of drinking water, household number, main source of income and estimated family income
Association of environmental sanitation with iodine intake
Environmental sanitation includes garbage disposal, drinking water, house premise, handwashing
Likability of a communication material on the knowledge of the mothers/caregivers regarding iodine, iodized salt and micronutrient powder
Included here is a survey on preference of communication material, preferred size, color and topic for Iodine, Iodized salt and micronutrient powder
Full Information
NCT ID
NCT02280330
First Posted
October 27, 2014
Last Updated
December 22, 2015
Sponsor
Nutrition Center of the Philippines
1. Study Identification
Unique Protocol Identification Number
NCT02280330
Brief Title
Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months
Acronym
MNP-CAR
Official Title
Iodine Intake & Status of Preschoolers Given Micronutrient Powder for 6 Months
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutrition Center of the Philippines
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Iodine deficiency remains widespread worldwide with children as among the vulnerable groups considering their stage of growth and development. In the Philippines, current data shows an optimal status among schoolchildren, however no data exists on iodine status nor intake of preschool children. One recent approach to improvement of the vitamin and mineral status of the population is home fortification using micronutrient powder or MNP. This contains 15 vitamins and minerals, including iodine and iron. Current guidelines exist for MNP use to improve iron status and reduce anemia among infants and young children 6-23 months old, but did not mention use among preschoolers such as those in day care centers. This study, therefore, aims to compare the iodine status and growth of day care children given MNP for 6 months.
Detailed Description
Iodine is an essential trace element for normal growth and development in animals and man (Hetzel, 1989). When iodine requirements are not met, thyroid hormone synthesis is impaired resulting in hypothyroidism and a series of functional and development abnormalities called iodine deficiency disorders or IDD develop (WHO, 2007).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iodine Deficiency, Iodine Deficiency Disorder, Hypothyroidism
Keywords
Iodine Deficiency, Micronutrient Powder, Hypothyroidism
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
396 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MNP group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MNP group
Other Intervention Name(s)
Multinutrient Powder
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo group
Other Intervention Name(s)
Placebo
Intervention Description
The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.
Primary Outcome Measure Information:
Title
Iodine status based on urinary iodine measures
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in growth as indicated by anthropometric parameters such as weight for age and height for age
Time Frame
6 months
Title
Levels of iodine intake
Time Frame
6 months
Title
Association of child characteristics with iodine intake
Description
Child characteristics include age, birth order, common illnesses
Time Frame
6 months
Title
Association of mother/caregiver characteristics with iodine intake
Description
Mother / Caregiver information includes age, religion, ethnic tribe, educational attainment, occupation and economic role in the family
Time Frame
6 months
Title
Association of household characteristics with iodine intake
Description
Household information includes status of residence, length of residence, type of residence, nature of living arrangement, source of drinking water, household number, main source of income and estimated family income
Time Frame
6 months
Title
Association of environmental sanitation with iodine intake
Description
Environmental sanitation includes garbage disposal, drinking water, house premise, handwashing
Time Frame
6 months
Title
Likability of a communication material on the knowledge of the mothers/caregivers regarding iodine, iodized salt and micronutrient powder
Description
Included here is a survey on preference of communication material, preferred size, color and topic for Iodine, Iodized salt and micronutrient powder
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imelda O Degay
Organizational Affiliation
University of the Philippines Los Banos
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Trinidad Benguet Day Care Centers
City
La Trinidad
State/Province
Benguet
ZIP/Postal Code
2601
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months
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