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Preventing Lack of Iodine During Pregnancy

NCT ID: NCT00379535

Last Updated: 2011-10-12

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.

Detailed Description

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374 patients with pregnancy less 12 weeks amenorrhea

Patients randomized in 2 parallel groups (each group with 187 patients)

* one group with 200 µg of potassium iodide
* one group with placebo

Follow up during 3 years with :

* a selection visit, an inclusion with randomization before 12 weeks amenorrhea
* and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and 6, 12, and 24 months " post partum "

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Daily dose of 200 µg of potassium iodide

Group Type EXPERIMENTAL

potassium iodide

Intervention Type DRUG

per os

2

Daily dose of placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

per os

Interventions

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potassium iodide

per os

Intervention Type DRUG

placebo

per os

Intervention Type DRUG

Other Intervention Names

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Iodence

Eligibility Criteria

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Inclusion Criteria

* Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy, unique or twiny
* Patients who agree to take part in the study and able to sign an Informed Consent Form

Exclusion Criteria

* Patients receiving a treatment for thyroid affection, or with thyroid pathology
* Patients with a chronic pathology like insulin dependent diabetes or arterial hypertension
* Patients with a treatment supplying iodine or having had a gynecologic exam with a iodine solution in the last 30 days
* Patients taking part in another clinical test or in the last 30 days
* Patients with depressive antecedent before pregnancy or taking antidepressant treatment
* Psychiatric troubles that may interfere with the clinical evaluation
* Patients under special supervision or trusteeship
* No social security cover
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CARON PHILIPPE, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

WEMEAU Jean-Louis, Pr

Role: STUDY_CHAIR

CHRU LILLE

NICCOLI-SIRE Patricia, Pr

Role: STUDY_CHAIR

CHU Timone MARSEILLE

BRUCKER-DAVIS Francoise, Dr

Role: STUDY_CHAIR

CHU NICE

Locations

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Endocrinology - University Hospital

Toulouse, , France

Site Status

Countries

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France

References

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Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Ressigeac P, Vertongen F, Grange V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54. doi: 10.1089/thy.1997.7.749.

Reference Type BACKGROUND
PMID: 9349578 (View on PubMed)

Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500.

Reference Type BACKGROUND

Other Identifiers

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PHRC

Identifier Type: -

Identifier Source: secondary_id

0501101

Identifier Type: -

Identifier Source: org_study_id