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Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development (MITCH)

This study has been completed.
St. John's Research Institute
Mahidol University
Unilever R&D
Swiss National Science Foundation
Nestlé Foundation
Information provided by (Responsible Party):
Alida Melse, Wageningen University Identifier:
First received: November 13, 2008
Last updated: November 16, 2016
Last verified: November 2016

Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of their offspring. However, the potential adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear. Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in iodine deficiency.

Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid function, pregnancy outcome, birth weight, infant growth and cognitive performance.

Study design: Double-blind randomized controlled multicentre trial. Study population: Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be recruited at two research sites, namely St. Martha's hospital in Bangalore, India and Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be recruited.

Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and the other half to placebo throughout pregnancy.

Main study parameters/endpoints: Differences between group means in indicators of thyroid function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor development.

Condition Intervention
Iodine Deficiency Infant Development Dietary Supplement: Placebo Dietary Supplement: Iodine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development

Resource links provided by NLM:

Further study details as provided by Alida Melse, Wageningen University:

Primary Outcome Measures:
  • Current primary outcome: Infant cognitive and motor development [ Time Frame: Regular intervals up till 6 years of age ]
  • Original primary outcome: Maternal thyroid function [ Time Frame: 3-month intervals during pregnancy, at delivery ]

Secondary Outcome Measures:
  • Birth outcome [ Time Frame: At delivery ]
  • Maternal and infant urinary iodine [ Time Frame: Regular intervals during pregnancy up till 2 years after delivery ]
  • Breast milk iodine [ Time Frame: 3 and 6 months after delivery ]
  • Long-term follow up [ Time Frame: Child age 2-6 years ]
    Anthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds

Enrollment: 829
Study Start Date: September 2008
Study Completion Date: May 2016
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Iodine
Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery
Placebo Comparator: 2 Dietary Supplement: Placebo
Daily placebo supplementation from enrolment <14 wk of gestation until delivery


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-40 years;
  • Gestational age: ≤ 14 weeks (as judged by the date of the last menstrual period);
  • Single pregnancy;
  • Non-lactating;
  • Planned residence in the area for the duration of the study (3 years).

Exclusion Criteria:

  • TSH levels outside the normal range
  • History of serious medical conditions such as HIV, hypertension, diabetes, renal, hepatic or cardiovascular disease, thyroid disorders, mental disorders;
  • Use of iodine supplement.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00791466

St. Johns Medical College and Research Institute
Bangalore, India, 560034
Insitute of Nutrition, Mahidol University (INMU)
Bangkok, Thailand, 73170
Sponsors and Collaborators
Wageningen University
St. John's Research Institute
Mahidol University
Unilever R&D
Swiss National Science Foundation
Nestlé Foundation
Principal Investigator: Michael Zimmermann, Prof. dr. Wageningen University
Principal Investigator: Alida Melse-Boonstra, PhD Wageningen University
  More Information

Responsible Party: Alida Melse, Dr., Wageningen University Identifier: NCT00791466     History of Changes
Other Study ID Numbers: MITCH-01
Study First Received: November 13, 2008
Last Updated: November 16, 2016

Keywords provided by Alida Melse, Wageningen University:
Iodine deficiency
Thyroid function
Infant development

Additional relevant MeSH terms:
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on September 20, 2017