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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months

NCT02280330

Iodine Deficiency Iodine Deficiency Disorder Hypothyroidism

COMPLETED PHASE4

Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment

NCT05901766

Iodine Deficiency Nutrition Poor Development, Infant +1 more

NOT_YET_RECRUITING PHASE4

Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children

NCT04419103

Nutritional Requirements

COMPLETED

Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

NCT00791466

Iodine Deficiency Infant Development

COMPLETED NA

Study of the Effect of Iodized Oil Supplementation During Infancy

NCT01126125

Iodine Deficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Iodine Deficiency Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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;

Group Type EXPERIMENTAL