Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Wageningen University St. Johns Medical College, Bangalore, India Mahidol University Unilever Holding B.V., Vlaardingen, the Netherlands Swiss National Science Foundation Nestle Foundation, Lausanne, Switzerland |
---|---|
Information provided by: | Wageningen University |
ClinicalTrials.gov Identifier: | NCT00791466 |
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.
Condition | Intervention |
---|---|
Iodine Deficiency Infant Development |
Dietary Supplement: Placebo Dietary Supplement: Iodine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 800 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Dietary Supplement: Iodine
Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery
|
2: Placebo Comparator |
Dietary Supplement: Placebo
Daily placebo supplementation from enrolment <14 wk of gestation until delivery
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India | |
St. Johns Medical College and Research Institute | Recruiting |
Bangalore, India, 560034 | |
Contact: Sumithra Mutthaya, PhD +91 80 25532037 sumithra@iphcr.res.in | |
Contact: Nidhi Jaikrishna, MSc nidhijaiswal@yahoo.com | |
Principal Investigator: Sumithra Mutthaya, PhD | |
Thailand | |
Insitute of Nutrition, Mahidol University (INMU) | Not yet recruiting |
Bangkok, Thailand, 73170 | |
Contact: Pattanee Wongmetinee, PhD : +66-2-889-2168 nupwn@mahidol.ac.th | |
Contact: Sueppong Gowachirapant, MSc +66-2-8002380 g_sueppong@yahoo.com | |
Principal Investigator: Pattanee Wongmetinee, PhD |
Principal Investigator: | Michael Zimmermann, Prof. dr. | Wageningen University |
Principal Investigator: | Alida Melse-Boonstra, PhD | Wageningen University |
Responsible Party: | Wageningen University, Division of Human Nutrition, the Netherlands ( Prof. Dr. Michael Zimmermann ) |
Study ID Numbers: | MITCH-01 |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00791466 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC); India: Institutional Review Board; Thailand: Ethical Committee |
Iodine deficiency Pregnancy Thyroid function Infant development Growth |
Iodine |
Anti-Infective Agents Anti-Infective Agents, Local Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |