RCT of Iodine-containing MNPs vs Oral Iodized Oil to Prevent Iodine Deficiency in Weaning Infants

January 27, 2017 updated by: Swiss Federal Institute of Technology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Except for the infant age criteria, the selection and exclusion criteria are the same for all participants (pilot and intervention):

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MNP90 + INERT OIL
Daily micronutrient powders (14 micronutrients) containing 90 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start;
Dietary supplement: MNP90
90 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
Dietary supplement: INERT OIL
Non-iodised evening primrose oil capsule; oral route; once at study start
Experimental: MNP45 + INERT OIL
Daily micronutrient powders (14 micronutrients) containing 45 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start;
Dietary supplement: INERT OIL
Non-iodised evening primrose oil capsule; oral route; once at study start
Dietary supplement: MNP45
45 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
Experimental: IODISED OIL + INERT MNP
Daily inert powder (maltodextrin, no micronutrients) plus one oral dose of 200 mg iodine as iodised poppy seed oil at the study start
Dietary supplement: IODISED OIL
200 mg iodine oil capsule; oral route; once at study start
Dietary supplement: INERT MNP
Un-fortified powder sachet (maltodextrin, no micronutrients); oral route; 1 daily
Active Comparator: NON-IODISED MNP + INERT OIL
Daily micronutrient powders (14 micronutrients) without iodine plus one inert oil capsule without iodine at the study start.
Dietary supplement: INERT OIL
Non-iodised evening primrose oil capsule; oral route; once at study start
Dietary supplement: NON-IODISED MNP
Un-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Infant urinary iodine concentration (UIC)
Time Frame: 24 weeks
24 weeks
Infant dried blood spot thyroglobulin (DBS-Tg)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant dried blood spot TSH (DBS-TSH)
Time Frame: 24 weeks
24 weeks
Infant dried blood spot total T4 (DBS-T4)
Time Frame: 24 weeks
24 weeks
Infant somatic growth (head circumference, weight, length)
Time Frame: 24 weeks, and if results significant at this point, 52 weeks
24 weeks, and if results significant at this point, 52 weeks
Thyroid autoimmunity
Time Frame: 24 weeks
Measurement of thyroid antibodies
24 weeks
Safety (Composite measure of infant morbidities and infant mortality)
Time Frame: 24 weeks
Composite measure of infant morbidities and infant mortality
24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Infant urinary creatinine concentration
Time Frame: 24 weeks
24 weeks
Infant urinary sodium concentration
Time Frame: 24 weeks
24 weeks
Mother urinary iodine concentration (UIC)
Time Frame: 24 weeks
24 weeks
Mother breast milk iodine concentration (BMIC)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Global Alliance for Improved Nutrition
UNICEF

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael B Zimmermann, MD, ETH Zuerich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK-2014-N-35 (Other Identifier: ETH Zuerich)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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