AzTrials
AzTrials

PregnancyPhase 3NCT00379535

Preventing Lack of Iodine During Pregnancy

A Phase 3 study testing potassium iodide in people with Pregnancy, run by University Hospital, Toulouse at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
potassium iodide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
1 siteFrance
Study dates
Dec 2006to Jun 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Endocrinology - University Hospital

    Toulouse, 31059

Other trials in France

About this study

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

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.

Read the 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 "
Conditions
Pregnancy
Being tested
potassium iodide, placebo
Keywords
pregnancy , lack of iodine, lack of iodine during pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • potassium iodideDrug

    Also called Iodence

    per os

  • placeboDrug

    per os

Study groups in NCT00379535
Study groupRoleWhat they receive
1ExperimentalDaily dose of 200 µg of potassium iodide
Receives: Drug: potassium iodide
2Placebo comparatorDaily dose of placebo
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (4)

  1. Prevalence of hypothyroxinemia and hypothyroidism during pregnancy

    Measured: 9 months max

  2. Change in the functional thyroid parameters of mother during iodine treatment

    Measured: 2 years

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

    Measured: 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2008
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
374 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379535
Sponsor's protocol ID
0501101
Other IDs
PHRC
Status last verified
Oct 2011
First submitted
21 Sep 2006
Last updated
12 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 9349578

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing potassium iodide in people with Pregnancy, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00379535, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in