Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months

Hypothyroidism Clinical Trial

— MNP-CAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280330
• Other study ID #: NCP-RPU-2014-0001
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2014
• Last updated: December 22, 2015
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Nutrition Center of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypothyroidism
• Iodine Deficiency
• Iodine Deficiency Disorder

Intervention

Dietary Supplement:
• 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.

Other:
• Placebo group
The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.

Locations

Country	Name	City	State
Philippines	La Trinidad Benguet Day Care Centers	La Trinidad	Benguet

Sponsors (1)

Lead Sponsor	Collaborator
Nutrition Center of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iodine status based on urinary iodine measures		6 months	No
Secondary	Change in growth as indicated by anthropometric parameters such as weight for age and height for age		6 months	No
Secondary	Levels of iodine intake		6 months	No
Secondary	Association of child characteristics with iodine intake	Child characteristics include age, birth order, common illnesses	6 months	No
Secondary	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	6 months	No
Secondary	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	6 months	No
Secondary	Association of environmental sanitation with iodine intake	Environmental sanitation includes garbage disposal, drinking water, house premise, handwashing	6 months	No
Secondary	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	6 months	No