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

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Iodine Deficiency

Study type

Observational

Funder types

Other

Identifiers

NCT02196337

EK 2013-N-82

Details and patient eligibility

About

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

Full 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.

Enrollment

8,000 patients

Sex

All

Ages

2 weeks to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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