Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months

NCT02280330 | Completed Phase 4 DMC

• 1 other identifier: NCP-RPU-2014-0001
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Iodine Deficiency; Iodine Deficiency Disorder; Hypothyroidism

Keywords

Iodine Deficiency; Micronutrient Powder; Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Iodine status based on urinary iodine measures

  6 months

Secondary Outcomes (7)

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

  6 months

• Levels of iodine intake

  6 months

• Association of child characteristics with iodine intake

  6 months

• Association of mother/caregiver characteristics with iodine intake

  6 months

• Association of household characteristics with iodine intake

  6 months

Study Arms (2)

MNP group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Multinutrient Powder

MNP group

Placebo group OTHER

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

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• apparently healthy
• permanent resident in the barangay or municipality
• years old
• with informed written parental consent
• whose mothers are willing to devote time for the survey

You may not qualify if:

• severely underweight
• with obvious clinical problem like goiter, congenital heart disease
• with plans of transferring residence outside the municipality within the next 6 months

Sponsors & Collaborators

• Nutrition Center of the Philippines: lead

Study Sites (1)

La Trinidad Benguet Day Care Centers

La Trinidad, Benguet, 2601, Philippines

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Imelda O Degay

  University of the Philippines Los Banos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

PH (1)