Effects of ω3-fatty acid supplement on blood vascular and systemic inflammation markers, oxidative stress , hematologic indices and Lp(a) in hemodialysis patients
The present study was designed to investigate the effects ω3-fatty acid supplement on blood vascular and systemic inflammation markers, Lp(a), oxidative stress and hematologic indices in hemodialysis patients.
In this double-blind randomized clinical trial, 40 hemodialysis patients were randomly assigned to either ω3-fatty acid or placebo group. The patients in the ω3-fatty acid supplement group received 2080 mg ω3-fatty acid as 4 capsules, each containing 310 mg eicosapentaenoic acid and 210 mg docosahexaenoic acid, daily for 10 weeks, while the placebo group received 4 corresponding placebo capsules containing MCT oil. Hb, Mct, RBC, MCV, MCH, MCHC and serum ICAM-1 were compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901263719N1
Registration date:2008-05-01, 1387/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-05-01, 1387/02/12
Registrant information
Name
akram kooshki
Name of organization / entity
Sabzevar university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 57 1264 4063
Email address
pajouhesh@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute of nutrition science and food technology
Expected recruitment start date
2008-05-01, 1387/02/12
Expected recruitment end date
2008-10-01, 1387/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ω3-fatty acid supplement on blood vascular and systemic inflammation markers, oxidative stress , hematologic indices and Lp(a) in hemodialysis patients
Public title
Effects of ω3-fatty acid supplement on blood vascular and systemic inflammation markers, oxidative stress , hematologic indices and Lp(a) in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Agreeing to enrol , at least six month past haemodialysis. Exclusion criteria: No infectious diseases, hepatic diseases, Lupus and rheumatoid arthritis, BMI<18.5 or BMI>25, consuming any the drugs including steroid, NSAID, statins, estrogens, progesterone, niacin and E or C vitamins one month prior to the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Institude Nurition Science and Food Technology
Street address
Institude Nurition Science and Food Technology
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
125
Health conditions studied
1
Description of health condition studied
hemodialyzed patient in Sabzevar
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis
Primary outcomes
1
Description
Blood hematological indices such as Hb, Hct, RBC, MCV, MCH, MCHC
Timepoint
10 weeks after consumption of Omega 3 supplement
Method of measurement
cell counter
Secondary outcomes
1
Description
Intercellular Adhesion Molecule - ICAM-1
Timepoint
10 weeks
Method of measurement
ElISA
Intervention groups
1
Description
The placebo group received 4 corresponding placebo capsules containing MCT oil
Category
Placebo
2
Description
ω3-fatty acid supplement group received 2080 mg ω3-fatty acid as 4 capsules, each containing 310 mg eicosapentaenoic acid and 210 mg docosahexaenoic acid, daily for 10 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Vasei hospital
Full name of responsible person
Mrs. Dowlatabadi
Street address
Sabzevar Vasei hospital
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Institute of Nurition Science
Full name of responsible person
Frogh Azam Taleban
Street address
Institute of Nurition Science
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute of Nurition Science
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
Institute of Nutrition Science and Food Technology
Full name of responsible person
Forogh Azam Taleban
Position
Professor
Other areas of specialty/work
Street address
Institute of Nutrition Science and Food Technology
City
Tehran
Postal code
Phone
+98 21 8809 6963
Fax
Email
talebanfa@yahoo.de
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Akram Kooshki
Position
Assistant professor
Other areas of specialty/work
Street address
Sabzevar University of Medical Science
City
Sabzevar
Postal code
9617643638
Phone
+98 57 1264 4063
Fax
+98 57 1444 6008
Email
akooshki.nutr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Akram Kooshki
Position
Assistant professor
Other areas of specialty/work
Street address
Sabzevar University of Medical Science
City
Sabzevar
Postal code
9617643638
Phone
+98 57 1264 4063
Fax
+98 57 1444 6008
Email
akooshki.nutr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)