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NCT04683211 Clinical Trial

Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

Gestational Diabetes Clinical Trial

— IODIAB  

Official title:
Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04683211
Other study ID # IDRCB 2020-A02570-39
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2021
Est. completion date May 11, 2021

Study information
Verified date May 2021
Source Centre Hospitalier Sud Francilien
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 11, 2021
Est. primary completion date April 21, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - pregnant woman with gestational diabetes - age = 18 years - subject informed of the study and not having opposed it. Exclusion Criteria: - already known pathology of the thyroid

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Evaluation of iodine supplementation
survey of iodine supplementation

Locations
Country Name City State
France Centre Hospitalier Sud Francilien Corbeil-essonnes

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Iodine supplementation µg/day Day 0
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