NCT03602404

Brief Summary

The overall objective of this study is to develop a reliable method to obtain habitual iodine intakes from spot urinary iodine concentration (UIC) and to assess the prevalence of inadequate iodine intake in school-age children and women of reproductive age. We will evaluate different methods to estimate iodine intake from UIC and estimate the prevalence of inadequate and excess iodine intake in UIC studies conducted in populations with low, adequate and high iodine intakes using the the established estimated average requirement (EAR)/Tolerable Upper Intake Level (UL) cut-point method.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

July 18, 2018

Last Update Submit

May 26, 2022

Conditions

Iodine Deficiency

Keywords

Iodine

Outcome Measures

Primary Outcomes (1)

  • Estimated iodine intake

    Estimated daily iodine intake of the study population derived from urinary iodine and creatinine concentrations measured in spot urine samples

    17 months

Secondary Outcomes (2)

  • Urinary iodine concentration

    17 months

  • Urinary creatinine concentration

    17 months

Study Arms (3)

St. Petersburg: School aged children

Generally healthy 9 to 12 years old children

St. Petersburg: Women of reproductive age

Generally healthy non-pregnant, non-lactating women between 18 and 44 years of age

Papua New Guinea: School aged children

Generally healthy 9 to 12 years old children

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Apparently healthy school-age children and women of reproductive age

You may qualify if:

  • lived in study area \>= 12 months
  • no reported intake of Amiodarone
  • no history of thyroid dysfunction / goiter (past \& present)
  • no exposure to iodine containing contrast agents within the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Papua New Guinea

Sia, Morobe Province, Papua New Guinea

Location

Almazov Medical Research Center

Saint Petersburg, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Spot urine samples Dried blood spots

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 18, 2018

First Posted

July 26, 2018

Study Start

June 1, 2018

Primary Completion

February 21, 2020

Study Completion

February 21, 2020

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)PA(1)