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

Iodine Deficiency Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196337
• Other study ID #: EK 2013-N-82
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: April 18, 2016
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 44 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Iodine Deficiency

Locations

Country	Name	City	State
China	Shanxi Institute for Prevention and Treatment of Endemic Disease	Linfen	Shanxi
Croatia	University of Zagreb	Zagreb
Philippines	University of Santo Tomas Hospital	Manila
Switzerland	ETH Zurich	Zurich

Sponsors (6)

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

Countries where clinical trial is conducted

China,  Croatia,  Philippines,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thyroid function (TSH, T4)	Thyroid function (TSH, T4) will be measured where relevant.	1 day	No
Other	Urinary sodium excretion (mg/day)	Urinary 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	1 day	No
Primary	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	No
Secondary	Thyroglobulin (µg/L)	Thyroglobulin will be measured in all population groups	1 day	No
Secondary	Breast milk iodine concentration (µg/L)	Breast milk iodine concentration will be measured in lactating women.	1 day	No