Iodine Supplementation During Pregnancy and Neuropsychological Development
NCT01049659
Healthy, Iodine Deficiency
Nice, France
View Trial DetailsNCT Number: NCT02196337
The purpose of this study is to determine whether universal salt iodization (USI) meets the iodine requirements of pregnant women, lactating women and infants.
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Notify Me2 week–44 year
All sexes
Observational
Shanxi Institute for Prevention and Treatment of Endemic Disease, Linfen, Shanxi, China
Because pregnant women, lactating women and infants are the groups most vulnerable to iodine deficiency and its irreversible consequences, programs should focus on these groups. But like other mass fortification strategies, it is uncertain whether USI can meet the increased dietary requirements of pregnant women, lactating women and infants. Objective of this study to test whether USI can meet the dietary requirements of iodine in women of reproductive age, pregnant women, lactating women and infants up to 2 years of age without causing excess iodine intake in school children and non-pregnant non-lactating women. The study hypothesis is that USI, when fortified at adequate levels and applied to all salt consumed, including both household salt and salt used for processed foods, provides adequate dietary iodine for all population groups, except for weaning infants; while not posing any risk of excessive iodine intakes in other age groups.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Time frame: 1 day
Participants will be assessed only once. However, for 30% of the study participants urinary iodine concentration will be assessed in spot samples collected on two different days, spread over an expected average of 5 days.
Time frame: 1 day
Thyroglobulin will be measured in all population groups
Time frame: 1 day
Breast milk iodine concentration will be measured in lactating women.
Time frame: 1 day
Thyroid function (TSH, T4) will be measured where relevant.
Time frame: 1 day
Urinary sodium excretion will be assessed in school age children and women of reproductive age. Participants will be assessed only once. However, for urinary sodium excretion 30% of the study participants will be assessed in spot samples collected on two different days, spread over an expected average of 5 days
Swiss Federal Institute of Technology
Other
Salt Iodization and the 1st 1000 Days: Does a USI Program Cover the Iodine Requirement of Pregnant and Lactating Women and Infants?
Acronym: SIMPLIFY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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