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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
Sponsor:
Collaborators:
Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal
Clinical Academic Center, 2CA-Braga, Portugal
Hospital de Braga
Administração Regional de Saúde do Norte, Portugal
Information provided by (Responsible Party):
Joana Almeida Palha, University of Minho

Brief Summary:
Full intellectual capabilities are achieved only if crucial nutrients are present during development. Iodine deficiency is the most common cause of preventable brain harm in infants. Because of its critical need during pregnancy, several countries implemented programs of iodine supplementation in preconception and pregnancy. In 2013, the prevalence of iodine deficiency in Portugal has led health authorities to issue a recommendation for iodine supplementation. This study aims to evaluate the impact of iodine supplementation on maternal and fetal iodine status and thyroid function, obstetric outcomes, quality of breast milk and child psychomotor development. It also intends to evaluate whether the time of iodine supplementation initiation influences all the above-mentioned parameters. The novelty and relevance of this study reside on the number of women/child and on the extent of health parameters that will be evaluated. The information collected will contribute to the detailed characterization of thyroid hormone homeostasis throughout pregnancy and its relationship with iodine supplementation (including time of initiation). The data will provide evidence on whether this iodine supplementation strategy impacted on iodine sufficiency of the mother and the newborns, or if it needs re-evaluation.

Condition or disease Intervention/treatment
Iodine Deficiency Thyroid Pregnancy Related Psychomotor Impairment Hypothyroidism in Pregnancy Nutrient Deficiency Dietary Supplement: Iodine supplementation

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Bayley scale assessed psychomotor development at one year of age [ Time Frame: One year of age ]
    Bayley psychomotor development scale


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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
Blood, Urine, Milk


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women from community health centers who intend to become pregnant or become pregnant and intend to delivery in the Hospital de Braga.
Criteria

Inclusion Criteria:

  • Women of who intend to become pregnant or are pregnant, able to read, write and provide informed consent

Exclusion Criteria:

  • Women transferred from outside the study health centres during pregnancy and women taking iodine supplementation before recruitment.
  • Women not intending to deliver at Hospital de Braga.

Information from the National Library of Medicine

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


Contacts
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Contact: Susana Roque, PhD +(351)910641862 iodominho@med.uminho.pt
Contact: Maria L Pereira, MD +(351)910641862 iodominho@med.uminho.pt

Locations
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Portugal
Usf Maxisaude Recruiting
Braga, Portugal, 4700-036
Contact: Carlos Falcão, MD    +(351)925084192    cfalcao@arsnorte.min-saude.pt   
Usf Braga Norte Recruiting
Braga, Portugal, 4700-395
Contact: Aparício Braga, MD    +(351)968022017    abbraga@arsnorte.min-saude.pt   
Usf Ruães Recruiting
Braga, Portugal, 4700-565
Contact: Ana Gomes, MD    +(351)963337974    amcogomes@arsnorte.min-saude.pt   
Usf S. Lourenço Recruiting
Braga, Portugal, 4705-414
Contact: Maria J Menezes, M    +(351)968925618    mjmenezes@arsnorte.min-saude.pt   
Usf Gualtar Recruiting
Braga, Portugal, 4710-078
Contact: Marcia Millet, MD    +(351)912571334    mmillet@arsnorte.min-saude.pt   
Usf + Carandá Recruiting
Braga, Portugal, 4710-406
Contact: Tahydi Collado, MD    +(351)917177070    trvcollado@arsnorte.min-saude.pt   
Usf Manuel Rocha Peixoto Recruiting
Braga, Portugal, 4715-123
Contact: João Samarão, MD       jsamarao@arsnorte.min-saude.pt   
Usf Bracara Augusta Recruiting
Braga, Portugal, 4715-213
Contact: José Machado, MD       jmmachado@arsnorte.min-saude.pt   
Usf Do Minho Recruiting
Braga, Portugal, 4715-402
Contact: Francisco F Gonzalez, MD    +(351)925090565    fgonzalez@arsnorte.min-saude.pt   
Usf S. João de Braga Recruiting
Braga, Portugal, 4715-402
Contact: Maria J Cabrita, MD       usfsjoao@arsnorte.min-saude.pt   
Sponsors and Collaborators
University of Minho
Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal
Clinical Academic Center, 2CA-Braga, Portugal
Hospital de Braga
Administração Regional de Saúde do Norte, Portugal
Investigators
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Principal Investigator: Joana A Palha, PhD School of Medicine, University of Minho
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joana Almeida Palha, Professor, University of Minho
ClinicalTrials.gov Identifier: NCT04288531    
Other Study ID Numbers: UMinho-IodineMinho
U1111-1247-2293 ( Other Identifier: World Health Organization )
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data that underlie results in a publication.
Supporting Materials: Study Protocol
Time Frame: Starting 6 months after publication
Access Criteria: Data will be provided for collaborative research purposes and for health authorities for public health recommendations. The Principal Investigator, research team and institution directive board will review the requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joana Almeida Palha, University of Minho:
Iodine
Human milk
Maternal health
Nutritional assessment
Thyroid hormones
Pregnancy
Population health
Congenital hypothyroidism
Psychomotor development
Additional relevant MeSH terms:
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Psychomotor Disorders
Thyroid Diseases
Hypothyroidism
Endocrine System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases