Objective: The present study was designed to investigate the effects of supplementation with carnitine and ubiquinone (Q10) to control CVD risk factors in HD patients under treatment with statin drugs.
Type of study: Randomized double blind placebo controlled clinical trial.
Population study: HD patients
Sample size: 52 HD patients (25 women and 27 men; mean age 53.3+14.2 years).
Inclusion criteria: 1) Patients under hemodialysis for at least one year; 2) Serum levels of lipoprotein (a) [Lp(a)] >20 mg/dl and homocysteine (Hcy) ≥15 mg/dl; 3) Willingness to participate and filling up the consent form.
Exclusion criteria: 1) Patients with acute or chronic infection; 2) Patients taking carnitine, ubiquinone, vitamins A, E and C during the last month prior to the trial.
Intervention: Patients were randomly divided into four groups, each of them received one of the following drugs: A) Carnitine 1000mg intravenously 3 times/week; B) Q10, 100 mg orally everyday; C) Carnitine+Q10; D) Placebo (n=13).
Duration: 3 months
Measurements: Fasting blood samples were collected at the beginning and at the end of trial for measuring serum levels of Lp(a), Hcy and malondialdehyde (MDA).
Primary outcomes: Carnitine and/or Q10 supplementation may reduce serum levels of Lp(a), Hcy and MDA in HD patients under treatment with statin drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811212779N2
Registration date:2010-04-15, 1389/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-15, 1389/01/26
Registrant information
Name
Fereydoun Siassi
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4924
Email address
siassif@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences and Health Services (TUMS)
Expected recruitment start date
2007-08-23, 1386/06/01
Expected recruitment end date
2007-11-21, 1386/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of carnitine , ubiquinone and both on the levels of serum Lp(a) and homocysteine and on the oxidative stress in heodialysis patients
Public title
Effects of carnitine , ubiquinone and both on the levels of serum Lp(a) and homocysteine and on the oxidative stress in heodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients under hemodialysis for at least one yer; 2. Serum levels of Lp(a) >20 mg/dl and homocysteine =>15 mg/dl; 3. Willingness to participate and filling up the consent form.
Exclusion criteria: 1. Patients with acute or chronic infection; 2. Patients taking carnitine, ubiquinone, vitamins A,E and C during the last month prior to the trial.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee; Vice Chancellor for Research; Tehran University of Medical Sciences and Health Ser
Street address
Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2007-03-19, 1385/12/28
Ethics committee reference number
4956-27-04-85
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
cardio-vascular risk factors
Timepoint
Before and after 3 months after intervention
Method of measurement
Serum levels of Lp(a) (Elisa); homocysteine (Enzymatic cycling); and malondialdehyde (spectophotometry).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Carnitine (1000mg iv, 3x/week)
Category
Treatment - Drugs
2
Description
Intervention: Ubiquinone (100mg/day, oral)
Category
Treatment - Drugs
3
Description
Intervention: Carnitine (1000mg iv, 3x/week) and ubiquinone (100mg/day, oral)
Category
Treatment - Drugs
4
Description
Control: saline (5cc iv, 3x/week) and lactose (100mg/d, oral)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital, Tehran
Full name of responsible person
Dr. Seyed Mohammad Reza Khatami
Street address
Imam-Khomeini Hospital, Keshavarz Blvd.,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Ghods St., Keshavarz Blv., Uni Adminstration Bldg, 6th floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Public Health; Tehran University of Medical Sciences and Health Services (TUMS)
Full name of responsible person
Dr. Mir-Hatef Shojaei
Position
PhD student
Other areas of specialty/work
Street address
Department of Nutrition and Biochemistry, School of Public Health, TUMS; P.O.Box 14155-6446
City
Tehran
Postal code
Phone
+98 21 8897 3903
Fax
+98 21 8898 9132
Email
hatef663@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences and Health Sevices
Full name of responsible person
Dr. Fereydoun Siassi
Position
Professor/Ph.D.
Other areas of specialty/work
Street address
Department of Nutrition and Biochemistry, School of Public Health, TUMS; P.O.Box 14155-6446
City
Tehran
Postal code
Phone
+98 21 8895 4924
Fax
+98 21 8898 9132
Email
siassif@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mir-Hatef Shojaei
Position
Student/PhD
Other areas of specialty/work
Street address
Dept. of Nutrition and Biochemistry, School of Public Health, TUMS; P.O.Box 14155-6446
City
Tehran
Postal code
Phone
+98 21 8897 3903
Fax
Email
hatef663@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)