Iodine DeficiencyMITCHNCT00791466
Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development
A study testing Iodine in people with Iodine Deficiency and Infant Development, run by Wageningen University at 2 sites in 2 countries.
Trial summary
Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Infant Development
- What is being tested?
- Iodine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 829 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2008to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years;
- Gestational age: ≤ 14 weeks (as judged by the date of the last menstrual period);
- Single pregnancy;
- Non-lactating;
- Planned residence in the area for the duration of the study (3 years).
Who cannot join
- TSH levels outside the normal range
- History of serious medical conditions such as HIV, hypertension, diabetes, renal, hepatic or cardiovascular disease, thyroid disorders, mental disorders;
- Use of iodine supplement.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Thailand1 site
Insitute of Nutrition, Mahidol University (INMU)
Bangkok, 73170
About this study
Official title: Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development
Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of their offspring. However, the potential adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear. Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in iodine deficiency.
Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid function, pregnancy outcome, birth weight, infant growth and cognitive performance.
Read more
Study design: Double-blind randomized controlled multicentre trial. Study population: Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be recruited at two research sites, namely St. Martha's hospital in Bangalore, India and Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be recruited.
Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and the other half to placebo throughout pregnancy.
Main study parameters/endpoints: Differences between group means in indicators of thyroid function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor development.
- Conditions
- Iodine Deficiency, Infant Development
- Being tested
- Placebo, Iodine
- Keywords
- Iodine deficiency, Pregnancy, Thyroid function, Infant development, Growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Daily placebo supplementation from enrolment <14 wk of gestation until delivery
IodineDietary supplement
Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Iodine |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current primary outcome: Infant cognitive and motor development
Measured: Regular intervals up till 6 years of age
Original primary outcome: Maternal thyroid function
Measured: 3-month intervals during pregnancy, at delivery
Secondary outcomes (4)
Birth outcome
Measured: At delivery
Maternal and infant urinary iodine
Measured: Regular intervals during pregnancy up till 2 years after delivery
Breast milk iodine
Measured: 3 and 6 months after delivery
Long-term follow up
Anthropometrics, urinary iodine, thyroid hormones, WPPS, BRIEF-P, hearing thresholds
Measured: Child age 2-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- St. John's Research Institute, Mahidol University, Unilever R&D, Swiss National Science Foundation, Nestlé Foundation
- Responsible party
- Principal investigator, Alida Melse, Wageningen University
- Investigators
- Michael Zimmermann, Prof. dr., Principal investigator, Wageningen UniversityAlida Melse-Boonstra, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791466
- Sponsor's protocol ID
- MITCH-01
- Acronym
- MITCH
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2008
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melse-Boonstra A, Gowachirapant S, Jaiswal N, Winichagoon P, Srinivasan K, Zimmermann MB. Iodine supplementation in pregnancy and its effect on child cognition. J Trace Elem Med Biol. 2012 Jun;26(2-3):134-6. doi: 10.1016/j.jtemb.2012.03.005. Epub 2012 May 8.
PubMed 22575544Gowachirapant S, Melse-Boonstra A, Winichagoon P, Zimmermann MB. Overweight increases risk of first trimester hypothyroxinaemia in iodine-deficient pregnant women. Matern Child Nutr. 2014 Jan;10(1):61-71. doi: 10.1111/mcn.12040. Epub 2013 Aug 13.
PubMed 23937433Jaiswal N, Melse-Boonstra A, Thomas T, Basavaraj C, Sharma SK, Srinivasan K, Zimmermann MB. High prevalence of maternal hypothyroidism despite adequate iodine status in Indian pregnant women in the first trimester. Thyroid. 2014 Sep;24(9):1419-29. doi: 10.1089/thy.2014.0071. Epub 2014 Jul 21.
PubMed 24923842Gowachirapant S, Jaiswal N, Melse-Boonstra A, Galetti V, Stinca S, Mackenzie I, Thomas S, Thomas T, Winichagoon P, Srinivasan K, Zimmermann MB. Effect of iodine supplementation in pregnant women on child neurodevelopment: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):853-863. doi: 10.1016/S2213-8587(17)30332-7. Epub 2017 Oct 10.
PubMed 29030199Verhagen NJE, Gowachirapant S, Winichagoon P, Andersson M, Melse-Boonstra A, Zimmermann MB. Iodine Supplementation in Mildly Iodine-Deficient Pregnant Women Does Not Improve Maternal Thyroid Function or Child Development: A Secondary Analysis of a Randomized Controlled Trial. Front Endocrinol (Lausanne). 2020 Oct 6;11:572984. doi: 10.3389/fendo.2020.572984. eCollection 2020.
PubMed 33123091
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development
- ClinicalTrials.gov ID
- NCT00791466
- Acronym / sponsor ID
- MITCH / MITCH-01
- Conditions
- Iodine Deficiency, Infant Development
- Keywords
- Iodine deficiency, Pregnancy, Thyroid function, Infant development, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- St. John's Research Institute, Mahidol University, Unilever R&D, Swiss National Science Foundation, Nestlé Foundation
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Nov 2008 (estimated)
- 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.
Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of their offspring. However, the potential adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear. Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in iodine deficiency.
Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid function, pregnancy outcome, birth weight, infant growth and cognitive performance.
Study design: Double-blind randomized controlled multicentre trial. Study population: Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be recruited at two research sites, namely St. Martha's hospital in Bangalore, India and Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be recruited.
Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and the other half to placebo throughout pregnancy.
Main study parameters/endpoints: Differences between group means in indicators of thyroid function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Iodine |
| 2 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40 years;
- Gestational age: ≤ 14 weeks (as judged by the date of the last menstrual period);
- Single pregnancy;
- Non-lactating;
- Planned residence in the area for the duration of the study (3 years).
Key exclusion criteria (3 listed)
- TSH levels outside the normal range
- History of serious medical conditions such as HIV, hypertension, diabetes, renal, hepatic or cardiovascular disease, thyroid disorders, mental disorders;
- Use of iodine supplement.
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 |
|---|---|---|
| PlaceboDaily placebo supplementation from enrolment <14 wk of gestation until delivery | Dietary supplement | 2 |
| IodineDaily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery | Dietary supplement | 1 |
Primary outcome
Current primary outcome: Infant cognitive and motor development
Time frame: Regular intervals up till 6 years of age
Original primary outcome: Maternal thyroid function
Time frame: 3-month intervals during pregnancy, at delivery
4 secondary outcomes
Birth outcome
Time frame: At delivery
Maternal and infant urinary iodine
Time frame: Regular intervals during pregnancy up till 2 years after delivery
Breast milk iodine
Time frame: 3 and 6 months after delivery
Long-term follow up
Time frame: Child age 2-6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 22575544Melse-Boonstra A, Gowachirapant S, Jaiswal N, Winichagoon P, Srinivasan K, Zimmermann MB. Iodine supplementation in pregnancy and its effect on child cognition. J Trace Elem Med Biol. 2012 Jun;26(2-3):134-6. doi: 10.1016/j.jtemb.2012.03.005. Epub 2012 May 8.
- Background: PubMed 23937433Gowachirapant S, Melse-Boonstra A, Winichagoon P, Zimmermann MB. Overweight increases risk of first trimester hypothyroxinaemia in iodine-deficient pregnant women. Matern Child Nutr. 2014 Jan;10(1):61-71. doi: 10.1111/mcn.12040. Epub 2013 Aug 13.
- Background: PubMed 24923842Jaiswal N, Melse-Boonstra A, Thomas T, Basavaraj C, Sharma SK, Srinivasan K, Zimmermann MB. High prevalence of maternal hypothyroidism despite adequate iodine status in Indian pregnant women in the first trimester. Thyroid. 2014 Sep;24(9):1419-29. doi: 10.1089/thy.2014.0071. Epub 2014 Jul 21.
- Background: PubMed 29030199Gowachirapant S, Jaiswal N, Melse-Boonstra A, Galetti V, Stinca S, Mackenzie I, Thomas S, Thomas T, Winichagoon P, Srinivasan K, Zimmermann MB. Effect of iodine supplementation in pregnant women on child neurodevelopment: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):853-863. doi: 10.1016/S2213-8587(17)30332-7. Epub 2017 Oct 10.
- Background: PubMed 33123091Verhagen NJE, Gowachirapant S, Winichagoon P, Andersson M, Melse-Boonstra A, Zimmermann MB. Iodine Supplementation in Mildly Iodine-Deficient Pregnant Women Does Not Improve Maternal Thyroid Function or Child Development: A Secondary Analysis of a Randomized Controlled Trial. Front Endocrinol (Lausanne). 2020 Oct 6;11:572984. doi: 10.3389/fendo.2020.572984. eCollection 2020.
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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.
Michael Zimmermann, Prof. dr. principal investigator
Wageningen University
Alida Melse-Boonstra, PhD principal investigator
Wageningen University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine in people with Iodine Deficiency and Infant Development, run by Wageningen University at 2 sites in 2 countries.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Thailand. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Current primary outcome: Infant cognitive and motor development (time frame: Regular intervals up till 6 years of age). The study lists 2 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 NCT00791466, which also lists 5 linked publications.
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 21 Nov 2022.