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Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00791466
Acronym
MITCH
Enrollment
829
Registered
2008-11-14
Start date
2008-09-30
Completion date
2016-05-31
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iodine Deficiency, Infant Development

Keywords

Iodine deficiency, Pregnancy, Thyroid function, Infant development, Growth

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Daily placebo supplementation from enrolment \<14 wk of gestation until delivery

DIETARY_SUPPLEMENTIodine

Daily supplementation with 200 µg iodine from enrolment \<14 wk of gestation until delivery

Sponsors

St. John's Research Institute
CollaboratorOTHER
Mahidol University
CollaboratorOTHER
Unilever R&D
CollaboratorINDUSTRY
Swiss National Science Foundation
CollaboratorOTHER
Nestlé Foundation
CollaboratorOTHER
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.

Design outcomes

Primary

MeasureTime frame
Original primary outcome: Maternal thyroid function3-month intervals during pregnancy, at delivery
Current primary outcome: Infant cognitive and motor developmentRegular intervals up till 6 years of age

Secondary

MeasureTime frameDescription
Birth outcomeAt delivery
Maternal and infant urinary iodineRegular intervals during pregnancy up till 2 years after delivery
Breast milk iodine3 and 6 months after delivery
Long-term follow upChild age 2-6 yearsAnthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds

Countries

India, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026