Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development (MITCH)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 13, 2008 | ||||||||
| Last Updated Date | November 13, 2008 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Maternal thyroid function [ Time Frame: 3-month intervals during pregnancy, at delivery ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development | ||||||||
| Official Title ICMJE | Iodine Supplementation in Pregnant Women Living in Mild-to-Moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | |||||||||
| Location Countries ICMJE | India, Thailand | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00791466 | ||||||||
| Other Study ID Numbers ICMJE | MITCH-01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Prof. Dr. Michael Zimmermann, Wageningen University, Division of Human Nutrition, the Netherlands | ||||||||
| Study Sponsor ICMJE | Wageningen University | ||||||||
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| Information Provided By | Wageningen University | ||||||||
| Verification Date | November 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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