NCT02196337

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

June 2, 2014

Last Update Submit

April 18, 2016

Conditions

Iodine Deficiency

Keywords

Iodine deficiency

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Thyroglobulin (µg/L)

    1 day

  • Breast milk iodine concentration (µg/L)

    1 day

Other Outcomes (2)

  • Thyroid function (TSH, T4)

    1 day

  • Urinary sodium excretion (mg/day)

    1 day

Study Arms (6)

Women of reproductive age

Age: 18-44 years

Pregnant women

Age: 18-44 years

Lactating women

Age: 18-44 years

Young infants

Age: younger than 6 months

Toddlers

Age: between 6 and 24 months

School-aged children

Age: 6-12 years

Eligibility Criteria

Age2 Weeks - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Shanxi Institute for Prevention and Treatment of Endemic Disease

Linfen, Shanxi, 041000, China

Location

University of Zagreb

Zagreb, 10000, Croatia

Location

University of Santo Tomas Hospital

Manila, Philippines

Location

ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 29659964DERIVED

  • 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.

    PMID: 28228508DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine, dried blood spots, breast milk

Study Officials

  • Maria Andersson, PhD

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 2, 2014

First Posted

July 22, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)CH(1)CR(1)CN(1)