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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
Sponsor:
Information provided by (Responsible Party):
Nutrition Center of the Philippines

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.

Condition or disease Intervention/treatment Phase
Iodine Deficiency Iodine Deficiency Disorder Hypothyroidism Dietary Supplement: MNP group Other: Placebo group Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health
Drug Information available for: Iodine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Iodine status based on urinary iodine measures [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Philippines
La Trinidad Benguet Day Care Centers
La Trinidad, Benguet, Philippines, 2601
Sponsors and Collaborators
Nutrition Center of the Philippines
Investigators
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Principal Investigator: Imelda O Degay University of the Philippines Los Banos

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Responsible Party: Nutrition Center of the Philippines
ClinicalTrials.gov Identifier: NCT02280330     History of Changes
Other Study ID Numbers: NCP-RPU-2014-0001
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by Nutrition Center of the Philippines:
Iodine Deficiency
Micronutrient Powder
Hypothyroidism
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Iodine
Trace Elements
Micronutrients
Anti-Infective Agents, Local
Anti-Infective Agents
Nutrients
Growth Substances
Physiological Effects of Drugs