NCT03277911

Brief Summary

Early diagnosis of thyroid and lipid disorders by regular screening, and treatment of such disorders in CKD patients may be highly beneficial to slow progression of CKD. The study will be conducted to investigate thyroid function and lipid profile in patients with chronic kidney disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Status
unknown

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

First Submitted

Initial submission to the registry

September 5, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

September 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

12 months

First QC Date

September 5, 2017

Last Update Submit

September 8, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • The study will be conducted to investigate thyroid function in patients with chronic kidney disease

    serum urea, creatinine, , triiodothyronine \[T3\], free thyroxin \[T4\], thyroid stimulating hormones \[TSH\]

    one year

  • The study will be conducted to investigate lipid profile in patients with chronic kidney disease

    serum urea, creatinine,high density lipoprotein \[HDL\] cholesterol, low density cholesterol, total cholesterol, triglyceride

    one year

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study will be conducted on 80 patients with chronic kidney disease at Assuit University hospital to investigate thyroid function and lipid profile in patients with CKD of stages (1-5) and 20 subjects as a normal control. A total of newly diagnosed and known CKD cases of stage 1-5 will be included in the study. Sample Size Calculation: * Group I: Controls-20 age and sex matched normal individuals. * Group II: Cases -40 patients with stage 1-3. * Group III: Cases -40 patients with stage 4 and 5

You may qualify if:

  • Patients with CKD stage (1-5).
  • Not known thyroid disorders.
  • Not in lipid lowering agents.

You may not qualify if:

  • Patients with known thyroid disorders, on medication affecting thyroid function and lipid lowering agents are excluded from the study.
  • CKD patients who were or underwent previous dialysis.
  • Nephrotic syndrome.
  • Obesity.
  • Patients on estrogens, corticosteroids, antithyroid drugs, dietary supplements.
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of clinical pathology department

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 11, 2017

Study Start

September 10, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2019

Last Updated

September 11, 2017

Record last verified: 2017-09