NCT05266794

Brief Summary

An Open labeled, Paralled, Randomized, Prospective, study was conducted on 60 patients who were randomized into 3 groups, 22, 20 and 18 patients in Control, Selenium and, Thiotacid groups respectively. Serum levels of ROS, CoQ10, and miRNA-126 were assessed at base line and after three months for all patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

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

January 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

February 18, 2022

Last Update Submit

March 1, 2022

Conditions

Antioxidative StressEnd Stage Renal Disease on Dialysis

Keywords

Oxidative stressAntioxidantsmitochondrial functionCoQ10miRNA-126Hemodialysis

Outcome Measures

Primary Outcomes (3)

  • Change in miRNA-126 level

    Fold expression

    3 months

  • Change ROS level (ng/ml)

    Using ELISA kit

    3 months

  • Change in Co Q10 level (ng/ml)

    Using ELISA kit

    3 months

Study Arms (3)

Control

NO INTERVENTION

25 hemodialysis patients who received their routine therapy only.

Selenium

ACTIVE COMPARATOR

23 hemodialysis patients who received Selenium 200µg once daily with their routine therapy just after the dialysis sessions for 3 months.

Drug: Selenium

Alpha Lipoic acid

ACTIVE COMPARATOR

20 hemodialysispatients who received Alpha Lipoic acid (ALA) (Thiotex fort®) 600mg once daily with their routine therapy just after the dialysis sessions for 3 months.

Drug: Alpha lipoic acid

Interventions

Alpha lipoic acidDRUG

20 patients who received Alpha Lipoic acid (ALA) (Thiotex fort®) 600mg once daily with their routine therapy just after the dialysis sessions for 3 months.

Alpha Lipoic acid
SeleniumDRUG

23 patients who received Selenium 200µg once daily with their routine therapy just a

Selenium

Eligibility Criteria

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

You may qualify if:

  • prevalent hemodialysis patients

You may not qualify if:

  • Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Interventions

Thioctic AcidSelenium

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipidsChalcogensElementsInorganic ChemicalsMinerals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 4, 2022

Study Start

January 22, 2019

Primary Completion

April 23, 2019

Study Completion

April 30, 2019

Last Updated

March 4, 2022

Record last verified: 2022-03

Locations

EG(1)