Iodine Deficiency DisordersNCT02421653
RCT of Iodine-containing MNPs vs Oral Iodized Oil to Prevent Iodine Deficiency in Weaning Infants
A study testing MNP90, MNP45 and IODISED OIL in people with Iodine Deficiency Disorders, run by Swiss Federal Institute of Technology.
Trial summary
In this study, two intervention strategies to address iodine deficiency and prevent iodine deficiency disorders in breast-fed weaning infants will be evaluated in a mild to moderate iodine-deficient population in Zamboanga del Norte, Philippines, Southeast Asia. Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency Disorders
- What is being tested?
- MNP90, MNP45 and IODISED OIL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- 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 6 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages:
- For pilot - aged 6 - 18 months (+2 weeks, no infant < 6 months)
- For intervention - aged 6 - 9 months (+2 weeks, no infant < 6 months)
- Born to a healthy singleton pregnancy
- Term (week 38 to 42) delivery
- Family residence at the study site for at least 12 months prior to the start of the study and anticipated residence for at least a further 12 months (mother and infant)
- Exclusively breastfed for at least 2 months, or if not, having received no other sources of iodine intake (in formula, supplements, or foods)
- Signed informed consent
Who cannot join
- Suffering from severe acute malnutrition(< 3 weight-for-height z-scores)
- Known history of medical illnesses
- Taking chronic medications (mother and infant)
- Use of iodine containing dietary supplements during the last 6 months (mother and infant)
- Exposure to iodine containing X-ray / CT contrast agent, skin disinfectants or medications during the last 6 months (mother and infant)
- Participation in any other clinical study (mother and infant) or participated in the pilot study (infant)
- NB: Severe Acute Malnutrition is defined as being below 3 standard deviations (SD) of the WHO standard for weight-for-height ratio for infants and children aged 6 to 60 months. All infants identified with SAM will be excluded from the study and referred to hospital or nutrition clinic for treatment.
About this study
Official title: A Randomised Controlled Trial of Iodine-containing Micronutrient Powders Versus Oral Iodised Oil to Prevent Iodine Deficiency in Weaning Infants
In this study, two intervention strategies to address iodine deficiency and prevent iodine deficiency disorders in breast-fed weaning infants will be evaluated in a mild to moderate iodine-deficient population in Zamboanga del Norte, Philippines, Southeast Asia.
Read the detailed description
Universal salt iodization (USI) is the most effective means to ensure optimal population iodine status and prevent iodine deficiency. In countries where USI is well implemented it is generally assumed that iodine requirements of infants are covered through breast milk. As infants wean from breast milk, at the age of 4-6 months, iodized salt programs likely contribute little to their iodine intakes. Home-prepared complementary foods have low native iodine content and pediatric guidelines recommend no extra salt be given to infants during the first year making the dietary sources of iodine limited. Weaning infants may therefore be particularly vulnerable to iodine deficiency and its effects.
Iodine is an essential micronutrient and an integral component of the thyroid hormones, needed for normal growth and development, particularly of the brain. Thyroid hormones play a critical role for development of the central nervous system from early fetal life until well after birth. Thyroid hormone insufficiency during postnatal development is associated with sensorimotor and language deficits and hypothyroidism in infancy is associated with poorer language, memory skills, fine motor, auditory processing, attention and executive processing.
In iodine deficient areas where iodized salt coverage is poor, WHO, UNICEF and the International Council for the Control of Iodine Deficiency Disorders (ICCIDD) recommend infants between 7 and 24 months be given a daily dose of 90 µg iodine (potassium iodate) or an annual dose of 200 mg iodine (iodised oil). The scientific evidence for this recommendation is weak, however, and it is uncertain under what conditions the two prevention strategies may be applied and which of the two is best when.
The objective of this study is to evaluate the efficacy and safety of the two recommended intervention strategies in iodine-deficient weaning infants. The need for high-quality controlled studies to better understand the potential contribution and synergy of alternative strategies to help achieve optimal iodine nutrition in different population groups and settings has recently been defined as a major research priority.
Following a cross-sectional, pilot study, we will conduct a randomized controlled trial to assess the efficacy of two daily doses of iodine as potassium iodate (90 µg, 100% of the WHO recommended dose, and 45 µg, 50% of the WHO recommended dose) and the annual dose of 200 mg iodine in iodised oil, via a randomized, controlled trial in weaning infants of lactating mothers living in an area affected by mild to moderate iodine deficiency in Zamboanga del Norte, Philippines, Southeast Asia.
We will compare the efficacy of each of the iodine doses against each other, and against micro-nutrients given alone, estimate the optimal level of iodine for inclusion in MNPs, and report on the safety of these interventions in weaning infants.
This study will provide important guidance to public health experts, governments and international organisations to ensure normal infant thyroid function and growth and development.
- Conditions
- Iodine Deficiency Disorders
- Being tested
- MNP90, MNP45, IODISED OIL, INERT OIL, INERT MNP
- Keywords
- Micronutrient powders, MNP, Weaning, Home fortification, Iodine, Iodine deficiency, Iodine Deficiency Disorder, IDD, Infant, Growth, Iodised oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNP90Dietary supplement
90 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
MNP45Dietary supplement
45 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
IODISED OILDietary supplement
200 mg iodine oil capsule; oral route; once at study start
INERT OILDietary supplement
Non-iodised evening primrose oil capsule; oral route; once at study start
INERT MNPDietary supplement
Un-fortified powder sachet (maltodextrin, no micronutrients); oral route; 1 daily
NON-IODISED MNPDietary supplement
Un-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
| Study group | Role | What they receive |
|---|---|---|
| MNP90 + INERT OIL | Experimental | Daily micronutrient powders (14 micronutrients) containing 90 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start; Receives: Dietary Supplement: MNP90; Dietary Supplement: INERT OIL |
| MNP45 + INERT OIL | Experimental | Daily micronutrient powders (14 micronutrients) containing 45 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start; Receives: Dietary Supplement: MNP45; Dietary Supplement: INERT OIL |
| IODISED OIL + INERT MNP | Experimental | Daily inert powder (maltodextrin, no micronutrients) plus one oral dose of 200 mg iodine as iodised poppy seed oil at the study start Receives: Dietary Supplement: IODISED OIL; Dietary Supplement: INERT MNP |
| NON-IODISED MNP + INERT OIL | Active comparator | Daily micronutrient powders (14 micronutrients) without iodine plus one inert oil capsule without iodine at the study start. Receives: Dietary Supplement: INERT OIL; Dietary Supplement: NON-IODISED MNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant urinary iodine concentration (UIC)
Measured: 24 weeks
Infant dried blood spot thyroglobulin (DBS-Tg)
Measured: 24 weeks
Secondary outcomes (5)
Infant dried blood spot TSH (DBS-TSH)
Measured: 24 weeks
Infant dried blood spot total T4 (DBS-T4)
Measured: 24 weeks
Infant somatic growth (head circumference, weight, length)
Measured: 24 weeks, and if results significant at this point, 52 weeks
Thyroid autoimmunity
Measurement of thyroid antibodies
Measured: 24 weeks
Safety (Composite measure of infant morbidities and infant mortality)
Composite measure of infant morbidities and infant mortality
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine Deficiency DisordersStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Global Alliance for Improved Nutrition
- Responsible party
- Sponsor
- Investigators
- Michael B Zimmermann, MD, Principal investigator, ETH Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421653
- Sponsor's protocol ID
- EK-2014-N-35
- Other IDs
- EK-2014-N-35
- Status last verified
- Jan 2017
- First submitted
- 11 Mar 2015
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Iodine-containing Micronutrient Powders Versus Oral Iodised Oil to Prevent Iodine Deficiency in Weaning Infants
- ClinicalTrials.gov ID
- NCT02421653
- Acronym / sponsor ID
- EK-2014-N-35
- Conditions
- Iodine Deficiency Disorders
- Keywords
- Micronutrient powders, MNP, Weaning, Home fortification, Iodine, Iodine deficiency, Iodine Deficiency Disorder, IDD
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- UNICEF, Global Alliance for Improved Nutrition
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Apr 2015 (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.
In this study, two intervention strategies to address iodine deficiency and prevent iodine deficiency disorders in breast-fed weaning infants will be evaluated in a mild to moderate iodine-deficient population in Zamboanga del Norte, Philippines, Southeast Asia.
Detailed description
Universal salt iodization (USI) is the most effective means to ensure optimal population iodine status and prevent iodine deficiency. In countries where USI is well implemented it is generally assumed that iodine requirements of infants are covered through breast milk. As infants wean from breast milk, at the age of 4-6 months, iodized salt programs likely contribute little to their iodine intakes. Home-prepared complementary foods have low native iodine content and pediatric guidelines recommend no extra salt be given to infants during the first year making the dietary sources of iodine limited. Weaning infants may therefore be particularly vulnerable to iodine deficiency and its effects.
Iodine is an essential micronutrient and an integral component of the thyroid hormones, needed for normal growth and development, particularly of the brain. Thyroid hormones play a critical role for development of the central nervous system from early fetal life until well after birth. Thyroid hormone insufficiency during postnatal development is associated with sensorimotor and language deficits and hypothyroidism in infancy is associated with poorer language, memory skills, fine motor, auditory processing, attention and executive processing.
In iodine deficient areas where iodized salt coverage is poor, WHO, UNICEF and the International Council for the Control of Iodine Deficiency Disorders (ICCIDD) recommend infants between 7 and 24 months be given a daily dose of 90 µg iodine (potassium iodate) or an annual dose of 200 mg iodine (iodised oil). The scientific evidence for this recommendation is weak, however, and it is uncertain under what conditions the two prevention strategies may be applied and which of the two is best when.
The objective of this study is to evaluate the efficacy and safety of the two recommended intervention strategies in iodine-deficient weaning infants. The need for high-quality controlled studies to better understand the potential contribution and synergy of alternative strategies to help achieve optimal iodine nutrition in different population groups and settings has recently been defined as a major research priority.
Following a cross-sectional, pilot study, we will conduct a randomized controlled trial to assess the efficacy of two daily doses of iodine as potassium iodate (90 µg, 100% of the WHO recommended dose, and 45 µg, 50% of the WHO recommended dose) and the annual dose of 200 mg iodine in iodised oil, via a randomized, controlled trial in weaning infants of lactating mothers living in an area affected by mild to moderate iodine deficiency in Zamboanga del Norte, Philippines, Southeast Asia.
We will compare the efficacy of each of the iodine doses against each other, and against micro-nutrients given alone, estimate the optimal level of iodine for inclusion in MNPs, and report on the safety of these interventions in weaning infants.
This study will provide important guidance to public health experts, governments and international organisations to ensure normal infant thyroid function and growth and development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MNP90 + INERT OIL | Experimental | Dietary Supplement: MNP90, Dietary Supplement: INERT OILDaily micronutrient powders (14 micronutrients) containing 90 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start; |
| MNP45 + INERT OIL | Experimental | Dietary Supplement: MNP45, Dietary Supplement: INERT OILDaily micronutrient powders (14 micronutrients) containing 45 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start; |
| IODISED OIL + INERT MNP | Experimental | Dietary Supplement: IODISED OIL, Dietary Supplement: INERT MNPDaily inert powder (maltodextrin, no micronutrients) plus one oral dose of 200 mg iodine as iodised poppy seed oil at the study start |
| NON-IODISED MNP + INERT OIL | Active comparator | Dietary Supplement: INERT OIL, Dietary Supplement: NON-IODISED MNPDaily micronutrient powders (14 micronutrients) without iodine plus one inert oil capsule without iodine at the study start. |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Ages:
- For pilot - aged 6 - 18 months (+2 weeks, no infant < 6 months)
- For intervention - aged 6 - 9 months (+2 weeks, no infant < 6 months)
- Born to a healthy singleton pregnancy
- Term (week 38 to 42) delivery
Key exclusion criteria (7 listed)
- Suffering from severe acute malnutrition(< 3 weight-for-height z-scores)
- Known history of medical illnesses
- Taking chronic medications (mother and infant)
- Use of iodine containing dietary supplements during the last 6 months (mother and infant)
- Exposure to iodine containing X-ray / CT contrast agent, skin disinfectants or medications during the last 6 months (mother and infant)
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 |
|---|---|---|
| MNP9090 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily | Dietary supplement | MNP90 + INERT OIL |
| MNP4545 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily | Dietary supplement | MNP45 + INERT OIL |
| IODISED OIL200 mg iodine oil capsule; oral route; once at study start | Dietary supplement | IODISED OIL + INERT MNP |
| INERT OILNon-iodised evening primrose oil capsule; oral route; once at study start | Dietary supplement | MNP45 + INERT OIL, MNP90 + INERT OIL, NON-IODISED MNP + INERT OIL |
| INERT MNPUn-fortified powder sachet (maltodextrin, no micronutrients); oral route; 1 daily | Dietary supplement | IODISED OIL + INERT MNP |
| NON-IODISED MNPUn-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily | Dietary supplement | NON-IODISED MNP + INERT OIL |
Primary outcome
Infant urinary iodine concentration (UIC)
Time frame: 24 weeks
Infant dried blood spot thyroglobulin (DBS-Tg)
Time frame: 24 weeks
5 secondary outcomes
Infant dried blood spot TSH (DBS-TSH)
Time frame: 24 weeks
Infant dried blood spot total T4 (DBS-T4)
Time frame: 24 weeks
Infant somatic growth (head circumference, weight, length)
Time frame: 24 weeks, and if results significant at this point, 52 weeks
Thyroid autoimmunity
Time frame: 24 weeks
Safety (Composite measure of infant morbidities and infant mortality)
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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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.
Michael B Zimmermann, MD principal investigator
ETH Zuerich
Questions about this trial
What is this clinical trial studying?
A study testing MNP90, MNP45 and IODISED OIL in people with Iodine Deficiency Disorders, run by Swiss Federal Institute of Technology.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Infant urinary iodine concentration (UIC) (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 30 Jan 2017.