- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00791466
Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development (MITCH)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Zimmermann, Prof. dr., Wageningen University
Publications and helpful links
General Publications
- Melse-Boonstra A, Gowachirapant S, Jaiswal N, Winichagoon P, Srinivasan K, Zimmermann MB. Iodine supplementation in pregnancy and its effect on child cognition. J Trace Elem Med Biol. 2012 Jun;26(2-3):134-6. doi: 10.1016/j.jtemb.2012.03.005. Epub 2012 May 8.
- Gowachirapant S, Melse-Boonstra A, Winichagoon P, Zimmermann MB. Overweight increases risk of first trimester hypothyroxinaemia in iodine-deficient pregnant women. Matern Child Nutr. 2014 Jan;10(1):61-71. doi: 10.1111/mcn.12040. Epub 2013 Aug 13.
- Jaiswal N, Melse-Boonstra A, Thomas T, Basavaraj C, Sharma SK, Srinivasan K, Zimmermann MB. High prevalence of maternal hypothyroidism despite adequate iodine status in Indian pregnant women in the first trimester. Thyroid. 2014 Sep;24(9):1419-29. doi: 10.1089/thy.2014.0071. Epub 2014 Jul 21.
- Gowachirapant S, Jaiswal N, Melse-Boonstra A, Galetti V, Stinca S, Mackenzie I, Thomas S, Thomas T, Winichagoon P, Srinivasan K, Zimmermann MB. Effect of iodine supplementation in pregnant women on child neurodevelopment: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):853-863. doi: 10.1016/S2213-8587(17)30332-7. Epub 2017 Oct 10.
- Verhagen NJE, Gowachirapant S, Winichagoon P, Andersson M, Melse-Boonstra A, Zimmermann MB. Iodine Supplementation in Mildly Iodine-Deficient Pregnant Women Does Not Improve Maternal Thyroid Function or Child Development: A Secondary Analysis of a Randomized Controlled Trial. Front Endocrinol (Lausanne). 2020 Oct 6;11:572984. doi: 10.3389/fendo.2020.572984. eCollection 2020.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MITCH-01
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