A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years - Full Text View

A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years (I2S2)

This study is not yet open for participant recruitment.

Verified by NHS Tayside, March 2008

First Received: March 14, 2008 No Changes Posted

Sponsors and Collaborators:	NHS Tayside University of Dundee University of Oxford
Information provided by:	NHS Tayside
ClinicalTrials.gov Identifier:	NCT00638092

Purpose

The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.

Condition	Intervention	Phase
Transient Hypothyroxinaemia	Drug: sodium iodide Drug: sodium chloride	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Chlorides Iodine Sodium chloride Sodium iodide

U.S. FDA Resources

Further study details as provided by NHS Tayside:

Primary Outcome Measures:

neurodevelopment status [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age. [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]

Estimated Enrollment:	1063
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental This is the hypothetical active arm	Drug: sodium iodide 30 micrograms/kg/day
B: Placebo Comparator this is the hypothetical placebo	Drug: sodium chloride 30 micrograms/kg/day

Eligibility

Ages Eligible for Study:	up to 42 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All infants born under 31 weeks gestation

Exclusion Criteria:

Mother exposed to excess iodine during pregnancy or delivery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638092

Contacts

Contact: Fiona Williams, Dr	01382 420117	f.l.r.williams@chs.dundee.ac.uk
Contact: Robert Hume, Professor	01382 632594	r.hume@dundee.ac.uk

Locations

United Kingdom, Angus
Ninewells Hospital and Medical School
Dundee, Angus, United Kingdom, DD1 9SY

Sponsors and Collaborators

NHS Tayside

University of Dundee

University of Oxford

Investigators

Study Chair:

Fiona Williams, Dr

University of Dundee

More Information

Additional Information:

Supports programme of work This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director of Research and Innovations ( Dr James Houston )
Study ID Numbers:	19026, EudraCT Number 2008-001024-31, REC Reference 08/S0501/31
Study First Received:	March 14, 2008
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00638092 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Tayside:

hypothyroxinaemia
preterm
iodine
neurodevelopmental outcome

Study placed in the following topic categories:

Iodine

ClinicalTrials.gov processed this record on September 10, 2009