RCT of Iodine-containing MNPs vs Oral Iodized Oil to Prevent Iodine Deficiency in Weaning Infants
- Conditions
- Iodine Deficiency Disorders
- Interventions
- Dietary Supplement: MNP45Dietary Supplement: MNP90Dietary Supplement: IODISED OILDietary Supplement: INERT OILDietary Supplement: INERT MNPDietary Supplement: NON-IODISED MNP
- Registration Number
- NCT02421653
- Lead Sponsor
- Swiss Federal Institute of Technology
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MNP45 + INERT OIL 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; MNP45 + INERT OIL MNP45 Daily micronutrient powders (14 micronutrients) containing 45 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start; NON-IODISED MNP + INERT OIL INERT OIL Daily micronutrient powders (14 micronutrients) without iodine plus one inert oil capsule without iodine at the study start. MNP90 + INERT OIL 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; MNP90 + INERT OIL MNP90 Daily micronutrient powders (14 micronutrients) containing 90 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start; IODISED OIL + INERT MNP IODISED OIL Daily inert powder (maltodextrin, no micronutrients) plus one oral dose of 200 mg iodine as iodised poppy seed oil at the study start IODISED OIL + INERT MNP 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 NON-IODISED MNP + INERT OIL NON-IODISED MNP Daily micronutrient powders (14 micronutrients) without iodine plus one inert oil capsule without iodine at the study start.
- Primary Outcome Measures
Name Time Method Infant urinary iodine concentration (UIC) 24 weeks Infant dried blood spot thyroglobulin (DBS-Tg) 24 weeks
- Secondary Outcome Measures
Name Time Method Infant dried blood spot TSH (DBS-TSH) 24 weeks Infant somatic growth (head circumference, weight, length) 24 weeks, and if results significant at this point, 52 weeks Safety (Composite measure of infant morbidities and infant mortality) 24 weeks Composite measure of infant morbidities and infant mortality
Thyroid autoimmunity 24 weeks Measurement of thyroid antibodies
Infant dried blood spot total T4 (DBS-T4) 24 weeks