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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02196337
Acronym
SIMPLIFY
Enrollment
8000
Registered
2014-07-22
Start date
2014-07-31
Completion date
2016-01-31
Last updated
2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iodine Deficiency

Keywords

Iodine deficiency

Brief summary

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

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.

Interventions

None listed

Sponsors

University of Zagreb
CollaboratorOTHER
St. Luke's Medical Center
CollaboratorOTHER
Global Alliance for Improved Nutrition
CollaboratorOTHER
UNICEF
CollaboratorOTHER
Shanxi Institute for Prevention and Treatment of Endemic Disease
CollaboratorUNKNOWN
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
2 Weeks to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary iodine concentration (µg/L)1 dayParticipants 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.

Secondary

MeasureTime frameDescription
Thyroglobulin (µg/L)1 dayThyroglobulin will be measured in all population groups
Breast milk iodine concentration (µg/L)1 dayBreast milk iodine concentration will be measured in lactating women.

Other

MeasureTime frameDescription
Thyroid function (TSH, T4)1 dayThyroid function (TSH, T4) will be measured where relevant.
Urinary sodium excretion (mg/day)1 dayUrinary 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

Countries

China, Croatia, Philippines, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026