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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791466
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : November 17, 2016
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

Brief Summary:

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 or disease Intervention/treatment Phase
Iodine Deficiency Infant Development Dietary Supplement: Placebo Dietary Supplement: Iodine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 829 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Iodine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00791466

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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
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Principal Investigator: Michael Zimmermann, Prof. dr. Wageningen University
Principal Investigator: Alida Melse-Boonstra, PhD Wageningen University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alida Melse, Dr., Wageningen University Identifier: NCT00791466    
Other Study ID Numbers: MITCH-01
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Keywords provided by Alida Melse, Wageningen University:
Iodine deficiency
Thyroid function
Infant development