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Completed

NCT Number: NCT02280330

Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

La Trinidad Benguet Day Care Centers

La Trinidad, Benguet, 2601, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MNP group

Dietary Supplement

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.

Other names: Multinutrient Powder

Placebo Group

Other

The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.

Other names: Placebo

Primary outcomes

  1. Iodine status based on urinary iodine measures

    Time frame: 6 months

Secondary outcomes

  1. Change in growth as indicated by anthropometric parameters such as weight for age and height for age

    Time frame: 6 months

  2. Levels of iodine intake

    Time frame: 6 months

  3. Association of child characteristics with iodine intake

    Time frame: 6 months

    Child characteristics include age, birth order, common illnesses

  4. Association of mother/caregiver characteristics with iodine intake

    Time frame: 6 months

    Mother / Caregiver information includes age, religion, ethnic tribe, educational attainment, occupation and economic role in the family

  5. Association of household characteristics with iodine intake

    Time frame: 6 months

    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

  6. Association of environmental sanitation with iodine intake

    Time frame: 6 months

    Environmental sanitation includes garbage disposal, drinking water, house premise, handwashing

  7. Likability of a communication material on the knowledge of the mothers/caregivers regarding iodine, iodized salt and micronutrient powder

    Time frame: 6 months

    Included here is a survey on preference of communication material, preferred size, color and topic for Iodine, Iodized salt and micronutrient powder

Sponsors and collaborators

Lead sponsor

Nutrition Center of the Philippines

Other

Registry information

Official study title

Iodine Intake & Status of Preschoolers Given Micronutrient Powder for 6 Months

Acronym: MNP-CAR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2014
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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