NCT01950260

Brief Summary

The study will try to answer the question of whether early treatment with levothyroxine at 4 weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low thyroid hormone levels).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 29, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

3.6 years

First QC Date

September 23, 2013

Results QC Date

April 2, 2019

Last Update Submit

October 11, 2019

Conditions

Graves' Disease

Keywords

Graves' diseaseRadioactive iodineHypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Overt Hypothyroidism

    Incidence of overt hypothyroidism at 8 weeks post radioactive iodine treatment (RAI). Overt hypothyroidism was defined as thyroid stimulating hormone (TSH) test result \> 3.0 milliunits per liter (mIU/L) or thyroid hormone free T4 (fT4) \< 0.8 nanograms per deciliter (ng/dL). Free T4 is the portion of total T4 thyroid hormone that is available to your tissues in your bloodstream.

    8 weeks

Secondary Outcomes (2)

  • Change in Hypothyroid-Health Related Quality of Life

    4 weeks, 8 weeks

  • Change in Thyroid Specific Quality of Life

    4 weeks, 8 weeks

Study Arms (2)

Levothyroxine

EXPERIMENTAL

In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.

Drug: Levothyroxine

Placebo

PLACEBO COMPARATOR

In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.

Other: Placebo

Interventions

LevothyroxineDRUG

Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).

Also known as: Thyroid hormone
Levothyroxine
PlaceboOTHER

Placebo to start at 4 weeks after RAI

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all adult patients (ages 18-70 years) with Graves' Disease (GD) who will receive radioactive iodine (RAI) ablation of the thyroid gland for treatment of GD

You may not qualify if:

  • clinically manifest Graves' ophthalmopathy (GO)
  • recent (\<1 yr.) history of arrhythmias or any history of ventricular arrhythmias
  • preexistent cardiomyopathy
  • malnutrition
  • psychiatric history that could get worse if patient remains persistently hyperthyroid
  • unlikely to return for the planned follow-up visits
  • unlikely to comply with the blood drawing schedule
  • unlikely to complete the hypothyroid-Health Related Quality of Life (HDQL) and Thyroid Specific (TSQ) questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Graves DiseaseHypothyroidism

Interventions

ThyroxineThyroid Hormones

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Marius N. Stan
Organization
Mayo Clinic
stan.marius@mayo.edu
507-284-2463

Study Officials

  • Marius Stan, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Endocrinology Consultant

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 29, 2019

Results First Posted

October 29, 2019

Record last verified: 2019-10

Locations

US(1)