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

NCT04288531 | Active Not Recruiting

• 2 other identifiers: UMinho-IodineMinhoU1111-1247-2293
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 10

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.

Conditions

Iodine Deficiency; Thyroid; Pregnancy Related; Psychomotor Impairment; Hypothyroidism in Pregnancy; Nutrient Deficiency

Keywords

Iodine; Human milk; Maternal health; Nutritional assessment; Thyroid hormones; Pregnancy; Population health; Congenital hypothyroidism; Psychomotor development

Outcome Measures

Primary Outcomes (3)

• Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region

  Urinary iodine.

  At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant.

• Impact of iodine supplementation on maternal serum parameters of thyroid function and urinary iodine in the 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.

  First trimester of pregnancy

• Bayley scale assessed psychomotor development at one year of age

  Bayley psychomotor development scale

  One year of age

Secondary Outcomes (4)

• 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 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).

• Iodine and energy composition of human milk 3 months after delivery

  Three months after delivery

• 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.

Study Arms (3)

Pregnant and pregnant to be on iodine supplementation

Women in preconception, pregnant and lactating, receiving iodine supplementation

Dietary Supplement: Iodine supplementation

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.

Interventions

Iodine supplementation DIETARY_SUPPLEMENT

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 on iodine supplementation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minho: lead
• Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal: collaborator
• Clinical Academic Center (2CA-Braga): collaborator
• Hospital de Braga: collaborator
• Administração Regional de Saúde do Norte, Portugal: collaborator

Study Sites (10)

Usf Maxisaude

Braga, 4700-036, Portugal

Location

Usf Braga Norte

Braga, 4700-395, Portugal

Location

Usf Ruães

Braga, 4700-565, Portugal

Location

Usf S. Lourenço

Braga, 4705-414, Portugal

Location

Usf Gualtar

Braga, 4710-078, Portugal

Location

Usf + Carandá

Braga, 4710-406, Portugal

Location

Usf Manuel Rocha Peixoto

Braga, 4715-123, Portugal

Location

Usf Bracara Augusta

Braga, 4715-213, Portugal

Location

Usf Do Minho

Braga, 4715-402, Portugal

Location

Usf S. João de Braga

Braga, 4715-402, Portugal

Location

Related Publications (1)

• Lopes-Pereira M, Roque S, Costa P, Quialheiro A, Santos NC, Goios A, Vilarinho L, Correia-Neves M, Palha JA. Impact of iodine supplementation during preconception, pregnancy and lactation on maternal thyroid homeostasis and offspring psychomotor development: protocol of the IodineMinho prospective study. BMC Pregnancy Childbirth. 2020 Nov 13;20(1):693. doi: 10.1186/s12884-020-03376-y.

  PMID: 33187482 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Urine, Milk

MeSH Terms

Conditions

Thyroid Diseases; Psychomotor Disorders; Congenital Hypothyroidism

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypothyroidism

Study Officials

• Joana A Palha, PhD

  School of Medicine, University of Minho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: January 10, 2020
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

PT (10)