IodineMinho: Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region

Sponsor

University of Minho (Other)

Overall Status

Recruiting

CT.gov ID

NCT04288531

Collaborator

Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal (Other), Clinical Academic Center (2CA-Braga) (Other), Hospital de Braga (Other), Administração Regional de Saúde do Norte, Portugal (Other)

304

Enrollment

Locations

Anticipated Duration (Months)

30.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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) 304 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 Design

Study Type:

Observational

Anticipated Enrollment :

304 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 :

Jan 10, 2020

Anticipated Primary Completion Date :

Jan 10, 2024

Anticipated Study Completion Date :

Jan 10, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region [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 [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 [One year of age]
Bayley psychomotor development scale

Secondary Outcome Measures

Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancy [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 [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 [Three months after delivery]
Iodine and energy composition (total proteins, lipids and carbohydrates).
Fetal heart rate and thyroid volume at age 3 months [Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.]
Fetal cardiotocography and thyroid ultrasound.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Usf Maxisaude	Braga	Portugal	4700-036
2	Usf Braga Norte	Braga	Portugal	4700-395
3	Usf Ruães	Braga	Portugal	4700-565
4	Usf S. Lourenço	Braga	Portugal	4705-414
5	Usf Gualtar	Braga	Portugal	4710-078
6	Usf + Carandá	Braga	Portugal	4710-406
7	Usf Manuel Rocha Peixoto	Braga	Portugal	4715-123
8	Usf Bracara Augusta	Braga	Portugal	4715-213
9	Usf Do Minho	Braga	Portugal	4715-402
10	Usf S. João de Braga	Braga	Portugal	4715-402