Clinical trial NCT02196337: Salt Iodization: Meeting the Needs of Pregnancy, Lactation and Infancy
Official title: Salt Iodization and the 1st 1000 Days: Does a USI Program Cover the Iodine Requirement of Pregnant and Lactating Women and Infants?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iodine Deficiency
Keywords: Iodine deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Zagreb
name: St. Luke's Medical Center
name: Global Alliance for Improved Nutrition
name: UNICEF
name: Shanxi Institute for Prevention and Treatment of Endemic Disease
First posted: 2014-07-22
Enrollment: 8000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In each of the four study countries, six population groups will be studied:

* women of reproductive age
* pregnant women
* lactating women
* young infants
* toddlers
* school-aged children

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.

Eligibility 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

Primary outcomes:
measure: Urinary iodine concentration (µg/L)
timeFrame: 1 day
Secondary outcomes:
measure: Thyroglobulin (µg/L)
timeFrame: 1 day
measure: Breast milk iodine concentration (µg/L)
timeFrame: 1 day
Other outcomes:
measure: Thyroid function (TSH, T4)
timeFrame: 1 day
measure: Urinary sodium excretion (mg/day)
timeFrame: 1 day
Locations:
city: Linfen
country: China
facility: Shanxi Institute for Prevention and Treatment of Endemic Disease
state: Shanxi
city: Zagreb
country: Croatia
facility: University of Zagreb
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: ETH Zurich
name: Maria Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dold S, Zimmermann MB, Jukic T, Kusic Z, Jia Q, Sang Z, Quirino A, San Luis TOL, Fingerhut R, Kupka R, Timmer A, Garrett GS, Andersson M. Universal Salt Iodization Provides Sufficient Dietary Iodine to Achieve Adequate Iodine Nutrition during the First 1000 Days: A Cross-Sectional Multicenter Study. J Nutr. 2018 Apr 1;148(4):587-598. doi: 10.1093/jn/nxy015.
citation: Dold S, Zimmermann MB, Aboussad A, Cherkaoui M, Jia Q, Jukic T, Kusic Z, Quirino A, Sang Z, San Luis TO, Vandea E, Andersson M. Breast Milk Iodine Concentration Is a More Accurate Biomarker of Iodine Status Than Urinary Iodine Concentration in Exclusively Breastfeeding Women. J Nutr. 2017 Apr;147(4):528-537. doi: 10.3945/jn.116.242560. Epub 2017 Feb 22.