Iodine DeficiencyPhase 4MNP-CARNCT02280330
Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months
A Phase 4 study testing MNP group in people with Iodine Deficiency and Iodine Deficiency Disorder, run by Nutrition Center of the Philippines at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Iodine Deficiency Disorder, Hypothyroidism
- What is being tested?
- MNP group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 sitePhilippines
- Study dates
- Nov 2014to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- severely underweight
- with obvious clinical problem like goiter, congenital heart disease
- with plans of transferring residence outside the municipality within the next 6 months
Trial locations and contacts
1 site in 1 country.
Philippines1 site
La Trinidad Benguet Day Care Centers
La Trinidad, Benguet, 2601
About this study
Official title: Iodine Intake & 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.
Read the 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.
- Being tested
- MNP group, Placebo group
- Keywords
- Iodine Deficiency, Micronutrient Powder, Hypothyroidism
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNP groupDietary supplement
Also called Multinutrient Powder
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.
Placebo groupOther
Also called Placebo
The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iodine status based on urinary iodine measures
Measured: 6 months
Secondary outcomes (7)
Change in growth as indicated by anthropometric parameters such as weight for age and height for age
Measured: 6 months
Levels of iodine intake
Measured: 6 months
Association of child characteristics with iodine intake
Child characteristics include age, birth order, common illnesses
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Association of environmental sanitation with iodine intake
Environmental sanitation includes garbage disposal, drinking water, house premise, handwashing
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrition Center of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imelda O Degay, Principal investigator, University of the Philippines Los Banos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280330
- Sponsor's protocol ID
- NCP-RPU-2014-0001
- Acronym
- MNP-CAR
- Status last verified
- Dec 2015
- First submitted
- 27 Oct 2014
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Intake & Status of Preschoolers Given Micronutrient Powder for 6 Months
- ClinicalTrials.gov ID
- NCT02280330
- Acronym / sponsor ID
- MNP-CAR / NCP-RPU-2014-0001
- Keywords
- Iodine Deficiency, Micronutrient Powder, Hypothyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Nutrition Center of the PhilippinesUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNP group | Active comparator | Dietary Supplement: MNP groupThe 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. |
| Placebo group | Placebo comparator | Other: Placebo groupThe 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- severely underweight
- with obvious clinical problem like goiter, congenital heart disease
- with plans of transferring residence outside the municipality within the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNP groupAlso: Multinutrient PowderMNP 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. | Dietary supplement | MNP group |
| Placebo groupAlso: PlaceboThe placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP. | Other | Placebo group |
Primary outcome
Iodine status based on urinary iodine measures
Time frame: 6 months
7 secondary outcomes
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
Association of mother/caregiver characteristics with iodine intake
Time frame: 6 months
Association of household characteristics with iodine intake
Time frame: 6 months
Association of environmental sanitation with iodine intake
Time frame: 6 months
Likability of a communication material on the knowledge of the mothers/caregivers regarding iodine, iodized salt and micronutrient powder
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
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The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imelda O Degay principal investigator
University of the Philippines Los Banos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MNP group in people with Iodine Deficiency and Iodine Deficiency Disorder, run by Nutrition Center of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iodine status based on urinary iodine measures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.