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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
History of Changes
  Purpose

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 Intervention Phase
Pregnancy
 Drug: potassium iodide
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Potassium
U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 374
Study Start Date: December 2006
Study Completion Date: June 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo

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 "
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00379535     History of Changes
Other Study ID Numbers: 0501101, PHRC
Study First Received: September 21, 2006
Last Updated: October 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Therapeutic Uses
 Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013