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

Completed

• Conditions: Iodine Deficiency

• Registration Number: NCT02196337
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study First Submitted: 2014-06-02
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary iodine concentration (µg/L)	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.

Secondary Outcome Measures

Name	Time	Method
Breast milk iodine concentration (µg/L)	1 day	Breast milk iodine concentration will be measured in lactating women.
Thyroglobulin (µg/L)	1 day	Thyroglobulin will be measured in all population groups

Trial Locations

Locations (4)

University of Santo Tomas Hospital; 🇵🇭 Manila, Philippines

ETH Zurich; 🇨🇭 Zurich, Switzerland

University of Zagreb; 🇭🇷 Zagreb, Croatia

Shanxi Institute for Prevention and Treatment of Endemic Disease; 🇨🇳 Linfen, Shanxi, China