Gestational DiabetesIODIABNCT04683211
Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes
An observational study of Gestational Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Evaluation of iodine supplementation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2021to 11 May 2021
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: Women with gestational diabetes
Who may be able to join
- pregnant woman with gestational diabetes
- age ≥ 18 years
- subject informed of the study and not having opposed it.
Who cannot join
- already known pathology of the thyroid
Trial locations and contacts
1 site in 1 country.
About this study
Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.
Read the detailed description
Physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. The iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. The general French population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. However, according to French studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. To maintain euthyroidism, the mother must increase her T4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d The thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. Our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.
- Conditions
- Gestational Diabetes
- Being tested
- Evaluation of iodine supplementation
- Keywords
- Iodine intake, iodine supplementation, gestational diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of iodine supplementationOther
survey of iodine supplementation
What is being measured
The primary outcome is the main question the study is designed to answer.
Iodine supplementation
µg/day
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start5 Jan 2021
- Primary completion21 Apr 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683211
- Sponsor's protocol ID
- 2020-A02570-39
- Acronym
- IODIAB
- Status last verified
- May 2026
- First submitted
- 17 Dec 2020
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT04683211
- Acronym / sponsor ID
- IODIAB / 2020-A02570-39
- Conditions
- Gestational Diabetes
- Keywords
- Iodine intake, iodine supplementation, gestational diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.
Detailed description
Physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. The iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. The general French population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. However, according to French studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. To maintain euthyroidism, the mother must increase her T4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d The thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. Our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with gestational diabetes
Key inclusion criteria (3 listed)
- pregnant woman with gestational diabetes
- age ≥ 18 years
- subject informed of the study and not having opposed it.
Key exclusion criteria (1 listed)
- already known pathology of the thyroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of iodine supplementationsurvey of iodine supplementation | Other | – |
Primary outcome
Iodine supplementation
Time frame: Day 0
µg/day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Centre Hospitalier Sud Francilien 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 22 May 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Iodine supplementation (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.