Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

Infant Development Clinical Trial

— MITCH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791466
• Other study ID #: MITCH-01
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: May 2016

Study information

• Verified date: November 2022
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 829
• Est. completion date: May 2016
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development
• Iodine Deficiency

Intervention

Dietary Supplement:
• Placebo
Daily placebo supplementation from enrolment <14 wk of gestation until delivery
• Iodine
Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery

Locations

Country	Name	City	State
India	St. Johns Medical College and Research Institute	Bangalore
Thailand	Insitute of Nutrition, Mahidol University (INMU)	Bangkok

Sponsors (6)

Lead Sponsor	Collaborator
Wageningen University	Mahidol University, Nestlé Foundation, St. John's Research Institute, Swiss National Science Foundation, Unilever R&D

Countries where clinical trial is conducted

India,  Thailand, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current primary outcome: Infant cognitive and motor development		Regular intervals up till 6 years of age
Primary	Original primary outcome: Maternal thyroid function		3-month intervals during pregnancy, at delivery
Secondary	Birth outcome		At delivery
Secondary	Maternal and infant urinary iodine		Regular intervals during pregnancy up till 2 years after delivery
Secondary	Breast milk iodine		3 and 6 months after delivery
Secondary	Long-term follow up	Anthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds	Child age 2-6 years