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CompletedNCT01631305Updated Mar 5, 2014

Levothyroxine for Children With Euthyroid Sick Syndrome

A Phase 4 interventional study of Levothyroxine and Calcium magnesia in Euthyroid Sick Syndrome, sponsored by Sinaloa Pediatric Hospital. Completed at 1 site in Mexico. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2014-03-05.

Sponsored by Sinaloa Pediatric Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Month to 17 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.

Read the detailed description

Children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit, will be randomised to receive either Levothyroxine or placebo, to determine if it diminishes mortality.

02

Conditions studied

  • Euthyroid Sick Syndrome

Keywords

  • Euthyroid Sick Syndromes
  • Thyroxine
  • Intensive care
03

In context

Lead sponsor

Sinaloa Pediatric Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All children aged 1 month to 17 years.
  • Admitted to pediatric intensive care unit.
  • TSH and thyroid hormones below age specific levels.

Exclusion criteria

Exclusion Criteria:

  • Known thyroid condition.
  • Brain death.
  • Gut conditions that contraindicate oral route.
  • Readmissions to intensive care unit.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Levothyroxine

    3 mcg/kg/day

    Drug: Levothyroxine

  • Placebo comparator
    Control

    Calcium magnesia.

    Other: Calcium magnesia

Interventions

  • 3 mcg/kg/day

    Also known as: Brand: Eutirox.

  • OtherCalcium magnesia

    Placebo.

06

What researchers measure

Primary outcomes

  1. All cause mortality

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary outcomes

  1. Length of time in intensive care

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  2. Ventilation days

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  3. Use of vasopressors

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  4. Thyroid hormones levels

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

07

Study locations

1 site
  • Sinaloa Pediatric Hospital
    Culiacán, Sinaloa 80200, Mexico
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01631305
Lead sponsor
Sinaloa Pediatric Hospital
Responsible party
Jesús Javier Martínez-García (Principal investigator, Sinaloa Pediatric Hospital) — Principal investigator
First posted
Jun 29, 2012
Start date
Jan 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 5, 2014

Study contacts

Jesus J Martinez, MD
study chair · Sinaloa Pediatric Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Thyroxine

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