Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months (MNP-CAR)
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|ClinicalTrials.gov Identifier: NCT02280330|
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : December 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Iodine Deficiency Iodine Deficiency Disorder Hypothyroidism||Dietary Supplement: MNP group Other: Placebo group||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Iodine Intake & Status of Preschoolers Given Micronutrient Powder for 6 Months|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: 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.
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 Name: Multinutrient Powder
Placebo Comparator: 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.
Other: Placebo group
The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.
Other Name: Placebo
- Iodine status based on urinary iodine measures [ Time Frame: 6 months ]
- Change in growth as indicated by anthropometric parameters such as weight for age and height for age [ Time Frame: 6 months ]
- Levels of iodine intake [ Time Frame: 6 months ]
- Association of child characteristics with iodine intake [ Time Frame: 6 months ]Child characteristics include age, birth order, common illnesses
- 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
- 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
- Association of environmental sanitation with iodine intake [ Time Frame: 6 months ]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 [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280330
|La Trinidad Benguet Day Care Centers|
|La Trinidad, Benguet, Philippines, 2601|
|Principal Investigator:||Imelda O Degay||University of the Philippines Los Banos|