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

November 16, 2022 updated by: Alida Melse, Wageningen University

Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

829

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bangalore, India, 560034
        • St. Johns Medical College and Research Institute
      • Bangkok, Thailand, 73170
        • Insitute of Nutrition, Mahidol University (INMU)

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

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Daily placebo supplementation from enrolment <14 wk of gestation until delivery
EXPERIMENTAL: 1
Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth outcome
Time Frame: At delivery
At delivery
Maternal and infant urinary iodine
Time Frame: Regular intervals during pregnancy up till 2 years after delivery
Regular intervals during pregnancy up till 2 years after delivery
Breast milk iodine
Time Frame: 3 and 6 months after delivery
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
Child age 2-6 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Michael Zimmermann, Prof. dr., Wageningen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (ESTIMATE)

November 14, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • MITCH-01

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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