Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/05/2005
Date assigned
19/07/2005
Last edited
11/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robert Hume

ORCID ID

Contact details

Division of Maternal and Child Health Sciences
University of Dundee
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

2005-002404-42

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Euthyroid2

Study hypothesis

1. We aim to determine whether enteral supplementation with iodine is effective in promoting a positive iodine balance in extreme preterm infants who are parenterally fed
2. To determine the efficacy of the oral versus the nasogastric route of iodine supplementation

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Transient hypothyroxinaemia

Intervention

Iodine supplementation 30 µg/kg/day versus placebo (sterile distilled water)

Intervention type

Drug

Phase

Not Specified

Drug names

Iodine

Primary outcome measures

Serum T4 levels

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Infants who are born earlier or at 30 weeks gestation and who mothers are able to give informed consent.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

44

Participant exclusion criteria

Infants born over 30 weeks gestation. Infants will be excluded from the study if their mother is known to be viral hepatitis/HIV positive, or if their mother has problems giving consent because of mental illness or communication difficulties. Infants with serious congenital anomaly will be excluded.

If any infant is found to have hypothyroidism, following routine Guthrie Card screening, they will be excluded from further study and treated with thyroxine.

Recruitment start date

01/09/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Maternal and Child Health Sciences
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Nethergate
University of Dundee
Dundee
DD1 4HN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24576827

Publication citations

  1. Protocol

    Williams F, Hume R, Ogston S, Brocklehurst P, Morgan K, Juszczak E, , A summary of the iodine supplementation study protocol (I2S2): a UK multicentre randomised controlled trial in preterm infants., Neonatology, 2014, 105, 4, 282-289, doi: 10.1159/000358247.

Additional files

Editorial Notes