ClinicalTrials.gov
ClinicalTrials.gov Menu

Preventing Lack of Iodine During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00379535
Recruitment Status : Terminated
First Posted : September 22, 2006
Last Update Posted : October 12, 2011
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: potassium iodide Drug: placebo Phase 3

Detailed Description:

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 "

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years
Study Start Date : December 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Daily dose of 200 µg of potassium iodide
Drug: potassium iodide
per os
Other Name: Iodence
Placebo Comparator: 2
Daily dose of placebo
Drug: placebo
per os



Primary Outcome Measures :
  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 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Prevalence of hypothyroxinemia and hypothyroidism during pregnancy [ Time Frame: 9 months max ]
  2. Change in the functional thyroid parameters of mother during iodine treatment [ Time Frame: 2 years ]
  3. Comparison of the psychometric development of children , for woman with and without treatment [ Time Frame: 6, 12, and 24 months ]
  4. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379535


Locations
France
Endocrinology - University Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Ministry of Health, France
Investigators
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

Publications:
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.

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00379535     History of Changes
Other Study ID Numbers: 0501101
PHRC
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by University Hospital, Toulouse:
pregnancy , lack of iodine
lack of iodine during pregnancy

Additional relevant MeSH terms:
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs