Iodine supplementation during pregnancy and its effects on children's cognitive development
The Importance of Iodine During Pregnancy for Future Brain Function : a Randomized Placebo-controlled Trial. Swedish Iodine in Pregnancy and Development in Children (SWIDDICH) Study
This study tests if giving pregnant women with low iodine a daily supplement can help their children think and learn better as they grow up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1275 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Göteborg University Academic / other |
| Locations | 4 sites (Umea, Västerbotten and 3 other locations) |
| Trial ID | NCT02378246 on ClinicalTrials.gov |
What this trial studies
This study investigates whether administering a daily tablet containing 150 μg of iodine, along with vitamins and minerals, to pregnant women with mild iodine deficiency can improve cognitive development in their children. It is a randomized, placebo-controlled trial conducted in Sweden, with follow-up assessments of children's cognitive development at various ages. The study also examines the interaction between iodine, selenium, and iron, and measures various thyroid-related biomarkers in both mothers and newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women under 13 weeks of gestation, aged 18-40, who intend to have a full-term pregnancy and can commit to the study protocol.
Not a fit: Patients with known thyroid disease or those with risk factors for thyroid disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the necessity of iodine supplementation during pregnancy to enhance cognitive outcomes in children.
How similar studies have performed: Previous studies have shown the importance of iodine in cognitive development, but this specific approach of supplementation in a mildly iodine-deficient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
PREGNANT WOMEN Inclusion criteria * Pregnant, week \<13 * Age 18-40 years * Intent of a full term pregnancy * Agreement of taking no iodide containing supplements during the study except for study supplement Exclusion Criteria * Known current thyroid disease * Risk factors for thyroid disease (history or heredity for thyroid, other autoimmune disease or symptoms of hypo-/hyperthyroidism) where the TSH is abnormal * Possibility to not attend to the protocol according to the investigator's opinion * Less than 6 months from previous pregnancy or lactating period * Vegan CONTROL WOMEN Inclusion criteria * Age 18-40 years * Agreeing not to take iodide containing supplements 1 week prior to the collecting of the samples. Exclusion criteria * Current thyroid disease * Risk factors for thyroid disease (history or heredity for thyroid or other autoimmune disease or symptoms of hypo-/hyperthyroidism) where the TSH is abnormal * Possibility to not attend to the protocol according to the investigator's opinion * Currently pregnant or lactating * Less than 6 months from previous pregnancy or lactating period * Vegans
Where this trial is running
Umea, Västerbotten and 3 other locations
- Umeå Universitet, Department of Clinical Sciences — Umea, Västerbotten, Sweden (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Linköping University Hospital — Linkoping, Sweden (Recruiting)
- Skövde, Sweden (Completed)
Study contacts
- Principal investigator: Helena Filipsson Nyström, Ass Prof — Center for Endocrinology and Metabolism, SAhlgrenska University Hospital
- Study coordinator: Sofia Manousou, PhD student
- Email: sofia.manousou@vgergion.se
- Phone: +46700595310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.