Iodine DeficiencyIodineMinhoNCT04288531
Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region
An observational study of Iodine Deficiency and Thyroid, run by University of Minho at 10 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Thyroid, Pregnancy Related
- What is being tested?
- Iodine supplementation
- How many people
- 304 participants
- Where
- 10 sitesPortugal
- Study dates
- 10 Jan 2020to 10 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women from community health centers who intend to become pregnant or become pregnant and intend to delivery in the Hospital de Braga.
Who may be able to join
- Women of who intend to become pregnant or are pregnant, able to read, write and provide informed consent
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Portugal10 sites
Usf Maxisaude
Braga, 4700-036
Usf Braga Norte
Braga, 4700-395
Usf Ruães
Braga, 4700-565
Usf S. Lourenço
Braga, 4705-414
Usf Gualtar
Braga, 4710-078
Usf + Carandá
Braga, 4710-406
Usf Manuel Rocha Peixoto
Braga, 4715-123
Usf Bracara Augusta
Braga, 4715-213
Usf Do Minho
Braga, 4715-402
Usf S. João de Braga
Braga, 4715-402
About this study
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)
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.
Read the 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.
- Conditions
- Iodine Deficiency, Thyroid, Pregnancy Related, Psychomotor Impairment, Hypothyroidism in Pregnancy, Nutrient Deficiency
- Being tested
- Iodine supplementation
- Keywords
- Iodine, Human milk, Maternal health, Nutritional assessment, Thyroid hormones, Pregnancy, Population health, Congenital hypothyroidism, Psychomotor development
- Medical subject headings
- Thyroid Diseases, Psychomotor Disorders, Congenital Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine supplementationDietary supplement
Recommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant and pregnant to be on iodine supplementation | Women in preconception, pregnant and lactating, receiving iodine supplementation Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region
Urinary iodine.
Measured: 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.
Measured: First trimester of pregnancy
Bayley scale assessed psychomotor development at one year of age
Bayley psychomotor development scale
Measured: One year of age
Secondary outcomes (4)
Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancy
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.
Measured: 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
Serum thyroid hormones (TSH and eventually total and free thyroxine as retrieved from the neonatal newborn screening) and urinary iodine.
Measured: 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
Iodine and energy composition (total proteins, lipids and carbohydrates).
Measured: Three months after delivery
Fetal heart rate and thyroid volume at age 3 months
Fetal cardiotocography and thyroid ultrasound.
Measured: Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start10 Jan 2020
- Primary completion10 Jan 2024
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Institute Dr. Ricardo Jorge, Clinical Academic Center (2CA-Braga), Hospital de Braga, Administração Regional de Saúde do Norte, Portugal
- Responsible party
- Principal investigator, Joana Almeida Palha, University of Minho
- Investigators
- Joana A Palha, PhD, Principal investigator, School of Medicine, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288531
- Sponsor's protocol ID
- UMinho-IodineMinho
- Other IDs
- U1111-1247-2293
- Acronym
- IodineMinho
- Status last verified
- Nov 2024
- First submitted
- 25 Feb 2020
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that underlie results in a publication.
Publications
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.
PubMed 33187482
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04288531
- Acronym / sponsor ID
- IodineMinho / UMinho-IodineMinho
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- National Health Institute Dr. Ricardo Jorge, Clinical Academic Center (2CA-Braga), Hospital de Braga, Administração Regional de Saúde do Norte, Portugal
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant and pregnant to be on iodine supplementation | – | Dietary Supplement: Iodine supplementationWomen in preconception, pregnant and lactating, receiving 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women from community health centers who intend to become pregnant or become pregnant and intend to delivery in the Hospital de Braga.
Key inclusion criteria (1 listed)
- Women of who intend to become pregnant or are pregnant, able to read, write and provide informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine supplementationRecommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation. | Dietary supplement | Pregnant and pregnant to be on iodine supplementation |
Primary outcome
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
4 secondary outcomes
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 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).
Iodine and energy composition of human milk 3 months after delivery
Time frame: Three months after delivery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 33187482Lopes-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.
- Individual participant dataSharing planned: Yes. Data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joana A Palha, PhD principal investigator
School of Medicine, University of Minho
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency and Thyroid, run by University of Minho at 10 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.