NCT01049659

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

January 12, 2010

Last Update Submit

March 26, 2026

Conditions

HealthyIodine DeficiencyPregnancy

Keywords

pregnancyiodine deficiencyneuropsychological development

Outcome Measures

Primary Outcomes (1)

  • neuropsychological test

    one time mesure- just one visit in the study

Study Arms (1)

neuropsychological tests

OTHER

neuropsychological assessment of children around their second birthday

Behavioral: Neuropsychological test

Interventions

Neuropsychological testBEHAVIORAL

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

neuropsychological tests

Eligibility Criteria

Age23 Months - 25 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • children of more of 25 months old
  • children with acute pathology
  • children with chronic pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology Department, Nice University Hospital

Nice, 06000, France

Location

Related Publications (1)

  • Fenichel P, Chevalier N, Lahlou N, Coquillard P, Wagner-Mahler K, Pugeat M, Panaia-Ferrari P, Brucker-Davis F. Endocrine Disrupting Chemicals Interfere With Leydig Cell Hormone Pathways During Testicular Descent in Idiopathic Cryptorchidism. Front Endocrinol (Lausanne). 2019 Jan 10;9:786. doi: 10.3389/fendo.2018.00786. eCollection 2018.

    PMID: 30687232RESULT

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Françoise BRUCKER-DAVIS, PhD

    Nice University Hospital

    PRINCIPAL INVESTIGATOR

  • Sylvie HIERONIMUS, PhD

    Nice University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 14, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)