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Iodine Supplementation During Pregnancy and Neuropsychological Development

NCT ID: NCT01049659

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Healthy Iodine Deficiency Pregnancy

Keywords

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pregnancy iodine deficiency neuropsychological development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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neuropsychological tests

neuropsychological assessment of children around their second birthday

Group Type OTHER

Neuropsychological test

Intervention Type BEHAVIORAL

Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old

Interventions

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Neuropsychological test

Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* children which mother were included in the precedent protocol(pregnancy vitamins with or without iodine)

Exclusion Criteria

* children of more of 25 months old
* children with acute pathology
* children with chronic pathology
Minimum Eligible Age

23 Months

Maximum Eligible Age

25 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Françoise BRUCKER-DAVIS, PhD

Role: PRINCIPAL_INVESTIGATOR

Nice University Hospital

Sylvie HIERONIMUS, PhD

Role: PRINCIPAL_INVESTIGATOR

Nice University Hospital

Locations

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Endocrinology Department, Nice University Hospital

Nice, , France

Site Status

Countries

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France

Other Identifiers

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09-PP-04

Identifier Type: -

Identifier Source: org_study_id