NCT00379535

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
374

participants targeted

Target at P25-P50 for phase_3 pregnancy

Timeline
Completed

Started Dec 2006

Typical duration for phase_3 pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

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

September 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

2 years

First QC Date

September 21, 2006

Last Update Submit

October 10, 2011

Conditions

Pregnancy

Keywords

pregnancy , lack of iodinelack of iodine during pregnancy

Outcome Measures

Primary Outcomes (1)

  • Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years

    2 years

Secondary Outcomes (4)

  • Prevalence of hypothyroxinemia and hypothyroidism during pregnancy

    9 months max

  • Change in the functional thyroid parameters of mother during iodine treatment

    2 years

  • Comparison of the psychometric development of children , for woman with and without treatment

    6, 12, and 24 months

  • Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment

    3 months

Study Arms (2)

1

EXPERIMENTAL

Daily dose of 200 µg of potassium iodide

Drug: potassium iodide

2

PLACEBO COMPARATOR

Daily dose of placebo

Drug: placebo

Interventions

potassium iodideDRUG

per os

Also known as: Iodence
1
placeboDRUG

per os

2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology - University Hospital

Toulouse, 31059, France

Location

Related Publications (2)

  • 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.

    PMID: 9349578BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Potassium Iodide

Intervention Hierarchy (Ancestors)

IodidesIodine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • CARON PHILIPPE, Pr

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

  • WEMEAU Jean-Louis, Pr

    CHRU LILLE

    STUDY CHAIR

  • NICCOLI-SIRE Patricia, Pr

    CHU Timone MARSEILLE

    STUDY CHAIR

  • BRUCKER-DAVIS Francoise, Dr

    CHU NICE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 22, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Study Completion

June 1, 2010

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

FR(1)