Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region (IodineMinho)
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|ClinicalTrials.gov Identifier: NCT04288531|
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment|
|Iodine Deficiency Thyroid Pregnancy Related Psychomotor Impairment Hypothyroidism in Pregnancy Nutrient Deficiency||Dietary Supplement: Iodine supplementation|
Iodine is essential for intellectual development. Its deficiency, alone, is the most frequent cause of preventable brain harm in infants. Iodine is required to synthesize thyroid hormones, key components of central nervous system development. Because of its relevance in pregnancy, several countries have implemented iodine supplementation programs in preconception, pregnancy and lactation.
Iodine deficiency has been previously shown in women of childbearing age in Portugal. Because of this, since 2013 the National Health Authorities have recommended supplementing iodine (200 ug/day) in preconception, pregnant and lactating women. However, the latest Cochrane review on the subject does not allow to conclude on whether iodine supplementation strategies implemented to date are efficient. Therefore, this study is of great public health interest.
The objectives are to:
- Evaluate whether the new policy of recommending iodine supplementation in preconception, throughout pregnancy and during lactation impacted on the prevalence of iodine deficiency in the Minho region of Portugal when compared to the same population before the recommendation.
- Evaluate whether the time of initiation of iodine supplementation (if any) influences the serum levels of thyroid hormones in the three trimesters of pregnancy.
- Evaluate whether the serum levels of thyroid hormones in the first trimester of pregnancy predict psychomotor development of the newborn at 12 months of age.
To achieve these aims the investigators will follow: i) 1000 women longitudinally, before, during the three trimesters of pregnancy (primary care Health Centres), at delivery and three months after delivery, ii) their children at birth, 3 and 12 months of age; ii) perform a detailed evaluation of parameters of thyroid function (mother and child) and of psychomotor development of the newborns.
Investigators expect to provide detailed characterization of thyroid hormone homeostasis before and throughout pregnancy, their relation with iodine supplementation (and its timing of administration, if any) and with thyroid hormone parameters and psychomotor development of the newborn.
With 6 years passed since the beginning of recommendation on iodine supplementation, this is an appropriate time to assess its effectiveness. The high number of samples and parameters to analyze make this a high-power study to support public health policies.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Observational Study on the Impact of Iodine Supplementation on Maternal and Child's Thyroid Hormone Homeostasis and on the Child's Psychomotor Development, in the Portuguese Minho Region (IodineMinho)|
|Actual Study Start Date :||January 10, 2020|
|Estimated Primary Completion Date :||January 10, 2024|
|Estimated Study Completion Date :||January 10, 2025|
Pregnant and pregnant to be on iodine supplementation
Women in preconception, pregnant and lactating, receiving iodine supplementation
Dietary Supplement: Iodine supplementation
Recommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation.
Pregnant and pregnant to be not on iodine supplementation
Women in preconception, pregnant or lactating, not receiving iodine supplementation
Women of childbearing age
Women of childbearing age not planning to become pregnant.
- Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region [ Time Frame: At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant. ]Urinary iodine.
- Impact of iodine supplementation on maternal serum parameters of thyroid function and urinary iodine in the first trimester of pregnancy [ Time Frame: First trimester of pregnancy ]Serum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-thyroperoxidase), urinary iodine.
- Bayley scale assessed psychomotor development at one year of age [ Time Frame: One year of age ]Bayley psychomotor development scale
- Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancy [ Time Frame: Serum thyroid hormones and urinary iodine before iodine supplementation (if any), 1st, 2nd, 3rd trimesters of pregnancy, after delivery. Thyroid ultrasound at baseline, 3rd trimester and 3 months after delivery. ]Serum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-peroxidase), urinary iodine, thyroid ultrasound.
- Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization of newborns [ Time Frame: One to 3 days of age (if full term babies), 1 to 3 days and 4th week of age (in premature and low birth weight babies). ]Serum thyroid hormones (TSH and eventually total and free thyroxine as retrieved from the neonatal newborn screening) and urinary iodine.
- Iodine and energy composition of human milk 3 months after delivery [ Time Frame: Three months after delivery ]Iodine and energy composition (total proteins, lipids and carbohydrates).
- Fetal heart rate and thyroid volume at age 3 months [ Time Frame: Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age. ]Fetal cardiotocography and thyroid ultrasound.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288531
|Contact: Susana Roque, PhD||+(351)email@example.com|
|Contact: Maria L Pereira, MD||+(351)firstname.lastname@example.org|
|Braga, Portugal, 4700-036|
|Contact: Carlos Falcão, MD +(351)925084192 email@example.com|
|Usf Braga Norte||Recruiting|
|Braga, Portugal, 4700-395|
|Contact: Aparício Braga, MD +(351)968022017 firstname.lastname@example.org|
|Braga, Portugal, 4700-565|
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|Usf S. Lourenço||Recruiting|
|Braga, Portugal, 4705-414|
|Contact: Maria J Menezes, M +(351)968925618 firstname.lastname@example.org|
|Braga, Portugal, 4710-078|
|Contact: Marcia Millet, MD +(351)912571334 email@example.com|
|Usf + Carandá||Recruiting|
|Braga, Portugal, 4710-406|
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|Usf Manuel Rocha Peixoto||Recruiting|
|Braga, Portugal, 4715-123|
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|Usf Bracara Augusta||Recruiting|
|Braga, Portugal, 4715-213|
|Contact: José Machado, MD firstname.lastname@example.org|
|Usf Do Minho||Recruiting|
|Braga, Portugal, 4715-402|
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|Usf S. João de Braga||Recruiting|
|Braga, Portugal, 4715-402|
|Contact: Maria J Cabrita, MD firstname.lastname@example.org|
|Principal Investigator:||Joana A Palha, PhD||School of Medicine, University of Minho|