Salt Iodization: Meeting the Needs of Pregnancy, Lactation and Infancy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether universal salt iodization (USI) meets the iodine requirements of pregnant women, lactating women and infants.

Detailed Description
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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.

Official Title
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Salt Iodization and the 1st 1000 Days: Does a USI Program Cover the Iodine Requirement of Pregnant and Lactating Women and Infants?

Conditions
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Iodine Deficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: living at study area for at least 6 months generally healthy no chronic medication no history of thyroid disease in the family no use of iodine containing dietary supplements during the last 6 months no use of iodine containing disinfectants for the last 6 months no use of X-ray / CT contrast agent or iodine containing medication within the last year in addition for women of reproductive age, pregnant women and breastfeeding women: age between 18 and 44 years old in addition for pregnant women: healthy pregnancy, singleton pregnancy (no twins or multiple pregnancy) in addition for breastfeeding women and breastfed infants: healthy pregnancy, singleton pregnancy (no twins or multiple pregnancy), baby born at full-term (in pregnancy week 38 to 42), the baby had normal birth weight (≥ 2500 g), baby not older than 6 months, baby currently completely breastfed (except for water, tea and juices) in addition for toddlers: between 6 and 24 months old

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women of reproductive age<br>Age: 18-44 years | |
| Pregnant women<br>Age: 18-44 years | |
| Lactating women<br>Age: 18-44 years | |
| Young infants<br>Age: younger than 6 months | |
| Toddlers<br>Age: between 6 and 24 months | |
| School-aged children<br>Age: 6-12 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary iodine concentration (µg/L) | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroglobulin (µg/L) | Thyroglobulin will be measured in all population groups | 1 day | 
| Breast milk iodine concentration (µg/L) | Breast milk iodine concentration will be measured in lactating women. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iodine deficiency