NCT02090907

Brief Summary

Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 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

May 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

March 12, 2014

Last Update Submit

March 17, 2014

Conditions

Subclinical Hypothyroidism

Keywords

Subclinical hypothyroidismAtherosclerosisCardiovascular diseaseEndothelial functionPrevention

Outcome Measures

Primary Outcomes (2)

  • Change from baseline flow-mediated dilation at 2 months

    Flow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.

    At baseline and then 2 months after treatment

  • Change from baseline intima-media thickness at 2 months

    Intima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.

    At baseline and then 2 months after treatment

Study Arms (2)

Levothyroxin

EXPERIMENTAL

In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.

Drug: Levothyroxine

Placebo

PLACEBO COMPARATOR

In the placebo group treatment regimen and advices are identical to that of the treatment group, except for using a pharmacologically neutral agent, with complete resemblance to the real treatment.

Drug: Placebo

Interventions

LevothyroxineDRUG
Levothyroxin
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • age 18 to 65
  • confirmed subclinical hypothyroidism

You may not qualify if:

  • receiving of other treatments for hypothyroidism
  • patients with other major medical disorders
  • smoking
  • hyperlipidemia
  • obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khorshid endocrinology clinic

Isfahan, Isfahan, Iran

Location

Related Publications (2)

  • Walsh JP, Bremner AP, Bulsara MK, O'Leary P, Leedman PJ, Feddema P, Michelangeli V. Subclinical thyroid dysfunction as a risk factor for cardiovascular disease. Arch Intern Med. 2005 Nov 28;165(21):2467-72. doi: 10.1001/archinte.165.21.2467.

    PMID: 16314542BACKGROUND

  • Alibaz Oner F, Yurdakul S, Oner E, Kubat Uzum A, Erguney M. Evaluation of the effect of L-thyroxin therapy on endothelial functions in patients with subclinical hypothyroidism. Endocrine. 2011 Oct;40(2):280-4. doi: 10.1007/s12020-011-9465-2. Epub 2011 Apr 20.

    PMID: 21505892BACKGROUND

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Nasmi Niknam, M.D.

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 18, 2014

Study Start

May 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

IR(1)