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

Information source: Swiss Federal Institute of Technology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Iodine Deficiency

Phase: N/A

Status: Recruiting

Sponsored by: Swiss Federal Institute of Technology

Official(s) and/or principal investigator(s):
Maria Andersson, PhD, Principal Investigator, Affiliation: University of Zurich

Overall contact:
Maria Andersson, PhD, Phone: +41 44 632 80 51, Email: maria.andersson@hest.ethz.ch

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.

Clinical Details

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 design: Time Perspective: Cross-Sectional

Primary outcome: Urinary iodine concentration (µg/L)

Secondary outcome:

Thyroglobulin (µg/L)

Breast milk iodine concentration (µg/L)

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

Minimum age: N/A. Maximum age: 44 Years. Gender(s): Both.

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

Locations and Contacts

Maria Andersson, PhD, Phone: +41 44 632 80 51, Email: maria.andersson@hest.ethz.ch

Tianjin Medical University, Tianjin 30070, China; Active, not recruiting

University of Zagreb, Zagreb 10000, Croatia; Recruiting
Zvonko Kusic, PhD, Phone: +385 (0)1 48 95 122, Email: zvonko.kusic@zg.t-com.hr

University for Development Studies, Tamale, Ghana; Not yet recruiting
Abdul-Razak Abizari, PhD, Phone: +233 243588774, Email: abizaria@yahoo.com

University of Santo Tomas Hospital, Manila, Philippines; Recruiting
Theo O San Luis, MD, Phone: +63 (917) 842-6697, Email: teofilosanluis@gmail.com

ETH Zurich, Zurich 8092, Switzerland; Active, not recruiting

Additional Information

Starting date: July 2014
Last updated: July 18, 2014

Page last updated: August 23, 2015

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