Mild cognitive disorder. Mild cognitive disorder
Conditions
Interventions
Intervention 1: Control group: group receives standard care of hemodialysis with placebo (2 times a day, for 12 weeks). The placebo is formulated in capsules of the same shape and size as the drug cap
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Hemodialysis patients with cognitive impairment
Exclusion criteria
Exclusion criteria: Patients with viral infections such as hepatitis B and C (active and inactive) and other active infections Patients with confirmed malignancy Pregnancy Lactation Alpha lipoic acid sensitivity At least three months have passed since their dialysis Dialysis patients treated with drugs not related to dialysis and CKD that have the possibility of drug interaction and dangerous consequences for the patient and have not been previously studied in terms of interaction with alpha lipoic acid (such as some drugs of convulsive patients, phenytoin, phenobarbital, digoxin, amiodarone , sodium valproate and...) Smoking Acute cardiovascular disease Liver disorders Active rheumatological disorders Taking antioxidant supplements (vitamin C, E, Omega 3), thyroxine hormone, anticoagulants and oral contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining the effect of alphalipoic acid on cognitive impairment in hemodialysis patients. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Mini–mental state examination and Montreal Cognitive Assessment tests.;The status of immune cells. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Evaluating the number of T CD4+, T CD8+, T CD4+/CD8+ lymphocytes, NK CD16+, NK CD56+ and CD19+, CD20+B lymphocytes by flowcytometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluating cardiovascular diseases. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Evaluation with cardiologist.;Blood pressure changes. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Evaluation with cardiologist.;Changes in HbA1C in diabetic patients. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Blood test.;Changes in smoking behavior. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Self-declaration in the questionnaire.;Changes in oxidant to prooxidant levels, malondialdehyde, superoxide dismutase, and catalase. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Blood test in laboratory.;Changes in inflammatory markers: C reactive protein and interleukin 6. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: Blood test in laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahin Ghorban Sabbagh
Mashhad University of Medical Sciences
Outcome results
None listed