Evaluating therapeutic effects of omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic
acid) on anemia and nutritional status in hemodialysis patients with depression
The purpose of this study is to evaluate the potential positive effects of omega-3 fatty acids on anemia and nutritional status in hemodialysis patients with depression.
Inclusion criteria: Age more than 16 years old; Initiation of hemodialysis from 3 months ago (at least); Beck depression score equal to or more than 16; Post-dialysis body mass index between 20 and 30.
Exclusion criteria: Active underlying chronic inflammatory diseases; Chronic infection and/or acute infection within last month; Asthma or Chronic obstructive pulmonary disease; Other psychiatric disorders; Hypothyroidism; High risk for bleeding; Ingestion of omega-3 supplements in the past 3 months; Intolerance or allergic reaction to
fish oil; Ingestion of medications effective on inflammatory markers within the last six weeks. Fifty hemodialysis patients with Beck depression score of equal to or more than16 will be randomized to receive omega-3 fatty acids (1800 mg per day orally) or placebo for 4 months. Before the initiation of the study and at the end of month 4 of the study, pre-dialysis blood samples (10 milliliters) will be taken from all patients to measure serum hemoglobin, transferring, albumin, pre-albumin concentrations . Body mass index, mid arm circumference and Beck depression score will be evaluated at these times as well. The potential effects of omega-3 fatty acids on these laboratory and clinical parameters will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202203043N5
Registration date:2012-04-10, 1391/01/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-10, 1391/01/22
Registrant information
Name
Simin Dashti-Khavidaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
dashtis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating therapeutic effects of omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic
acid) on anemia and nutritional status in hemodialysis patients with depression
Public title
Evaluating therapeutic effects of omega-3 fatty acids on anemia and nutritional status in hemodialysis patients with depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 16 years old; Thrice weekly hemodialysis from the last three months (at least); The patient's ability to understand and sign the consent form; Use of biocompatible hemodialysis membrane; Proper functioning of arteriovenus fistula or indwelling catheter; Beck depression score equal to or more than 16; Post-dialysis body mass index between 20 and 30
Exclusion Criteria: Pregnancy; Active, uncontrolled or severe chronic inflammatory disease (autoimmune diseases, active connective tissue diseases,
malignancy, AIDS, hepatic and pulmonary diseases); Chronic infection or acute infection in a recent month; Life expectancy of less than 4 months; Asthma or Chronic obstructive pulmonary disease; Other concurrent Psychiatric disorders; Hypothyroidism; Hemoglubinopathies and other causes of anemia (other than iron deficiency); Simultaneous participation in other trials (Drug or Supplemental); History of medical (like MI or Strock) or surgical illness in the last three months; Malabsorption syndrome; Bleeding disorders (including coagulopathy) or high risk for bleeding; Diet change in a recent month; Consumption of omega-3 supplements in the past 3 months; Intolerance or allergy to fish oil; Use of drugs effective on inflammatory factors (like corticosteroides or other immunosuppressives,
Non-steroidal antiinflammatory drugs, contraceptives, Pentoxifylline) in the past 6 weeks; Concurrent use of antidepressants, antipsychotics, antiepileptics (other than gabapentin), methyldopa, cimetidine and serotonergic agents (like triptans, tramadol, tryptophan and linezolid); Warfarin therapy
; Alcohol abuse and other materials that cause dependency
Age
From 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Research deputy of Tehran University of Medical Sciences
Street address
4th Floor, Central Organization of Tehran University of Medical Sciences, Qods Avenue, Keshavarz Boulevard Steet, Tehran, Iran
City
Tehran
Postal code
1417653761
Approval date
2012-02-27, 1390/12/08
Ethics committee reference number
91-01-33-17020
Health conditions studied
1
Description of health condition studied
Anemia
ICD-10 code
D63.8*
ICD-10 code description
Anaemia in other chronic diseases classified elsewhere
2
Description of health condition studied
Nutritional Status
ICD-10 code
E44
ICD-10 code description
Protein-energy malnutrition of moderate and mild degree
3
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
4
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Serum Albumin Level
Timepoint
Immediately before starting the intervention and immediately after intervention completion
Method of measurement
colorimetric method particularly the bromcresol green (BCG) assay
2
Description
Serum pre-albumin Level
Timepoint
Immediately before starting the intervention and immediately after intervention completion
Method of measurement
Eliza Kit
3
Description
Serum Transferrin Level
Timepoint
Immediately before starting the intervention and immediately after intervention completion
Method of measurement
Immunoturbidimetric assay
4
Description
Body Mass Index (BMI)
Timepoint
Immediately before starting the intervention and immediately after intervention completion
Method of measurement
Weight (Kg) divided by Height (m) square
5
Description
Mid-arm circumference
Timepoint
Immediately before starting the intervention and immediately after intervention completion
Method of measurement
By measuring tape
6
Description
Hemoglobin level
Timepoint
Immediately before starting the intervention, monthly and after intervention