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Clinical Trials/NCT06412744
NCT06412744TerminatedNot Applicable

Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate?

Maastricht University Medical Center1 site in 1 country43 target enrollmentStarted: October 6, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
43
Locations
1
Primary Endpoint
Median urinary iodine excretion (µg/d)

Study Overview

Brief Summary

Study to determine iodine status in dutch pregnant women

Detailed Description

Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism. During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications. Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining. Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women. Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here it is proposed to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. It is hypothesised that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 18-45y old
  • in first 16 weeks of pregnancy
  • pregnant of singleton

Exclusion Criteria

  • Thyroid-disease or any other metabolic disease
  • kidney disease
  • twin-pregnancy

Outcomes

Primary Outcomes

Median urinary iodine excretion (µg/d)

Time Frame: At baseline measurement

Median urinary iodine excretion (µg/d)

Secondary Outcomes

  • Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)(At baseline measurement)
  • Nutritional intake specifically related to iodine intake (questionnaire)(At baseline measurement)
  • Urinary volume(At baseline measurement)
  • Smoking status (smoking is interfering with iodine metabolism)(At baseline measurement)
  • Intake other relevant micronutrients for pregnant(At baseline measurement)
  • Thyroglobulin and thyroglobulin antibody concentrations in blood serum(At baseline measurement)
  • Creatinin concentration in urine(At baseline measurement)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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