Iodine Supplementation During Pregnancy and Neuropsychological Development
The investigators have shown that Nice area, like most of France, remains an area of mild iodine deficiency. The investigators want to assess the potential benefit of early iodine supplementation during pregnancy in women with normal thyroid function on the neuropsychological development of their children assessed at the age of two with the Bayley test.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effect of Iodine Supplementation and During Pregnancy on Neuropsychological Development of Children Assessed at 2 Years Old|
- neuropsychological test [ Time Frame: one time mesure- just one visit in the study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
neuropsychological assessment of children around their second birthday
Behavioral: Neuropsychological test
Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old
Iodine is required for the synthesis of thyroid hormones. During pregnancy, iodine needs are increased to cover maternal and fetal thyroid hormones synthesis and the increased renal iodine clearance. Maternal hypothyroidism and/or severe iodine deficiency are associated to mental retardation in their offspring. Indeed, thyroid hormones and iodine are necessary for fetal brain development.
Iodine deficiency remains the first cause of preventable mental retardation. In France, preventive programs with salt iodine fortification are insufficient to eradicate iodine deficiency. In previous studies, we have shown that iodine deficiency is the rule for pregnant women in our area: 66 to 85% of women tested depending on the stage of pregnancy (Brucker-Davis 2004, Hieronimus et al 2009, abstract at the 2008 ETA and SFE meetings, article in preparation reporting results from our 2006 PHRC: Study of thyroid function during pregnancy with or without iodine supplementation).We will study the impact of early iodine supplementation in normal pregnant women on the neuropsychological development of their offspring assessed at 2 years of age. This is the follow-up of a cohort of children born to women enrolled in our 2006 PHRC. 110 healthy women have been included in this prospective study: they were seen early (median 8 weeks of gestation) and had strictly normal thyroid function tests, as well as no personal thyroid history. They were randomized into two groups: group A taking pregnancy vitamins without iodine supplementation (Oligobs GrossesseR 2 tablets/day) our group B taking the same vitamins but iodine fortified (Oligobs MaxiodeR 2 tablets per day, i.e. 150 mcg of iodine/day).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049659
|Endocrinology Department, Nice University Hospital|
|Nice, France, 06000|
|Principal Investigator:||Françoise BRUCKER-DAVIS, PhD||Nice University Hospital|
|Principal Investigator:||Sylvie HIERONIMUS, PhD||Nice University Hospital|