Iodine supplementation
Dietary SupplementRecommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation.
NCT Number: NCT04288531
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.
This study is active but is not currently recruiting participants.
18 year–50 year
Female
Observational
Usf + Carandá, Braga, Portugal
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Recommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation.
Time frame: At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant.
Urinary iodine.
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.
Time frame: One year of age
Bayley psychomotor development scale
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.
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.
Time frame: Three months after delivery
Iodine and energy composition (total proteins, lipids and carbohydrates).
Time frame: Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.
Fetal cardiotocography and thyroid ultrasound.
University of Minho
Other
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)
Acronym: IodineMinho
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