Skip to main content
OpenTrials
Completed

NCT Number: NCT02196337

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

2 week–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Urinary iodine concentration (µg/L)

    Time frame: 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 outcomes

  1. Thyroglobulin (µg/L)

    Time frame: 1 day

    Thyroglobulin will be measured in all population groups

  2. Breast milk iodine concentration (µg/L)

    Time frame: 1 day

    Breast milk iodine concentration will be measured in lactating women.

Other outcomes

  1. Thyroid function (TSH, T4)

    Time frame: 1 day

    Thyroid function (TSH, T4) will be measured where relevant.

  2. Urinary sodium excretion (mg/day)

    Time frame: 1 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

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Global Alliance for Improved Nutrition
  • Shanxi Institute for Prevention and Treatment of Endemic Disease
  • St. Luke's Medical Center
  • UNICEF
  • University of Zagreb

Registry information

Official study title

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

Acronym: SIMPLIFY

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.