Clinical trial NCT02280330: Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months
Official title: Iodine Intake & Status of Preschoolers Given Micronutrient Powder for 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iodine Deficiency
Iodine Deficiency Disorder
Hypothyroidism
Keywords: Iodine Deficiency
Micronutrient Powder
Hypothyroidism
Lead sponsor: Nutrition Center of the Philippines
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 396
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Iodine status based on urinary iodine measures
timeFrame: 6 months
Secondary outcomes:
measure: Change in growth as indicated by anthropometric parameters such as weight for age and height for age
timeFrame: 6 months
measure: Levels of iodine intake
timeFrame: 6 months
measure: Association of child characteristics with iodine intake
timeFrame: 6 months
measure: Association of mother/caregiver characteristics with iodine intake
timeFrame: 6 months
measure: Association of household characteristics with iodine intake
timeFrame: 6 months
measure: Association of environmental sanitation with iodine intake
timeFrame: 6 months
measure: Likability of a communication material on the knowledge of the mothers/caregivers regarding iodine, iodized salt and micronutrient powder
timeFrame: 6 months
Other outcomes:
Locations:
city: La Trinidad
country: Philippines
facility: La Trinidad Benguet Day Care Centers
state: Benguet
Study officials:
affiliation: University of the Philippines Los Banos
name: Imelda O Degay
role: PRINCIPAL_INVESTIGATOR
References: