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Evaluation of the effect of Alfa lipoic acid, Vitamin E supplementation and their combination on long term complications in patients on hemodialysis, Shiraz, 2010

Evaluation of the effect of Alfa lipoic acid, Vitamin E supplementation and their combination on oxidative stress, lipid profile, insulin resistance, inflammation and nutritional status in patients on hemodialysis, Shiraz, 2010

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201103156072N1
Enrollment
96
Registered
2011-04-15
Start date
2011-01-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End stage of renal disease (hemodialysis). Chronic renal failure

Interventions

Intervention 1: alpha-lipoic acid intake ,600mg per day, for 2 months. Intervention 2: Vitamin E intake, 400IU per day ,for 2 months. Intervention 3: alph-lipoic acid 600mg+VitaminE400IU, per day,for
Treatment - Drugs
Placebo
alpha-lipoic acid intake ,600mg per day, for 2 months
Vitamin E intake, 400IU per day ,for 2 months
alph-lipoic acid 600mg+VitaminE400IU, per day,for 2 months
placebo intake for 2 months

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 20-60 years, hemodialysis, twice a week, undergoing maintenance hemodialysis for more than 1 year, no receiving antioxidant supplements such as VitE, VitC, or fish oil Exclusion criteria: smoking, pregnancy, presence of acute inflammatory and infectious diseases, presence of liver or Rheumatic diseases (such as lupus,...), cardiac diseases, or cancer, use of anticoagulants or contraceptives thyroxin

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hs-CRP. Timepoint: Before and 2 months after intervention. Method of measurement: ELISA kit.;Malon-dialdehide (MDA). Timepoint: Before and 2 months after intervention. Method of measurement: Spectrophotometry.;Interlukin-6 (IL6). Timepoint: Before and 2 months after intervention. Method of measurement: RIA.

Secondary

MeasureTime frame
Insulin. Timepoint: Before and 2 months after intervention. Method of measurement: ELISA kit.;Lipid profile. Timepoint: Before and 2 months after intervention. Method of measurement: Auto analyser.;FBS. Timepoint: Before and 2 months after intervention. Method of measurement: Auto analyser.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegin Mazouji

School of Health And Nutrition, Shiraz University of Mediccal Sciences

negin.mazouji@yahoo.com+98 71 1725 1001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026