Preventing Lack of Iodine During Pregnancy

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00379535
First received: September 21, 2006
Last updated: October 10, 2011
Last verified: October 2011

September 21, 2006
October 10, 2011
December 2006
December 2008   (final data collection date for primary outcome measure)
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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT00379535 on ClinicalTrials.gov Archive Site
  • Prevalence of hypothyroxinemia and hypothyroidism during pregnancy [ Time Frame: 9 months max ] [ Designated as safety issue: No ]
  • Change in the functional thyroid parameters of mother during iodine treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Comparison of the psychometric development of children , for woman with and without treatment [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: Yes ]
  • Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • prevalence of hypothyroxinemie and hypothyroidism during pregnancy
  • change in the functional thyroid parameters of mother during iodine treatment
  • comparison of the psychometric development of children at 6, 12, and 24 months, for woman with and without treatment
  • quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment
Not Provided
Not Provided
 
Preventing Lack of Iodine During Pregnancy
Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years

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.

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 "
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pregnancy
  • Drug: potassium iodide
    per os
    Other Name: Iodence
  • Drug: placebo
    per os
    Other Name: placebo
  • Experimental: 1
    Daily dose of 200 µg of potassium iodide
    Intervention: Drug: potassium iodide
  • Placebo Comparator: 2
    Daily dose of placebo
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
374
June 2010
December 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00379535
0501101, PHRC
No
University Hospital, Toulouse
University Hospital, Toulouse
Ministry of Health, France
Principal Investigator: CARON PHILIPPE, Pr CHU Toulouse
Study Chair: WEMEAU Jean-Louis, Pr CHRU LILLE
Study Chair: NICCOLI-SIRE Patricia, Pr CHU Timone MARSEILLE
Study Chair: BRUCKER-DAVIS Francoise, Dr CHU Nice
University Hospital, Toulouse
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP