L-carnitine effects on anemia improvement in patients undergoing hemodialysis

The study of effect of L-carnitine supplementation on anemia in hemodialysis patients

Clinical trials having a control group, community parallel study, double-blind, randomized groups

This study will be performed in dialysis unit of Tohid hospital in Sanandaj by 100 patients with chronic renal failure, divided into two groups of 50. Patients in both the intervention and control groups and the nurses who provide the drug and the placebo to the patients will not be aware of the type of drug, and a completely same form of the drug and the placebo will be delivered to the patients. Patients in the intervention group treated by L-carnitine with a dose of 1 gr per day and the control group without L-carnitine, they received placebo for 12 weeks. Mean serum hemoglobin, ferritin and iron will be measured before and three months after starting treatment.

Inclusion criteria 1. Patients with chronic renal failure who are undergoing hemodialysis 2. Age over 20 years 3. Previous at least one year of hemodialysis treatment Non-inclusion criteria: 1. Infectious, hepatic, and malignant diseases 2. Previous consumption of L-Carnitine supplement 3. Use of corticosteroids 4. Narcotic drugs, alcohol and cigarette consumption

The intervention group will receive L-carnitine at a dose of 1 g per day for three months. The control group will receive the placebo.

Hemoglobin, Iron, Ferritin, and Total Iron Binding Capacity(TIBC)

Random allocation method was used to assign participants in blocks of four. There are six probabilities for block size of four (six cards). A hundred participants were assigned randomly using the cards twenty-five times. AABB ABAB BBAA BAAB ABBA BABA The first choice was done using simple randomizing method and table of random numbers. Having selected the first card, other participants are selected according to the rounds. Cards labelled (A) referred to intervention group, and cards labelled (B) referred to control group. Therefore, fifty participants are assigned in each group (intervention and control). Sampling will continue until all the participants are assigned in the groups randomly.

Patients in both the intervention and control groups and the nurses who provide the drug and the drug to the patients will not be aware of the type of drug. The placebo was similar to the drug in terms of shape, color, size, weight and packaging

Regarding the fact that the present study has been registered as a research project in the “Research Management System of Medical Sciences University of Kurdistan”, it is required to present and register the final report in the “National Health Research Results Database”. Therefore, the sharing process of this study will be done step by step accordingly. It is essential to mention than the results of this study will be published in terms of statistical data, tables and figures in the extracted paper.

One year

Everyone

After publishing article

Regarding the fact that presenting and registering the results of the study in a profile on “National Health Research Database” of Medical Sciences University of Kurdistan, and publishing the final paper and registering the researchers’ information in the mentioned database, it will be possible to contact the researchers through emailing and deputy of research and technology of the university.

The researchers will be willing to respond emails requesting information, which is not considered confidential and private, about the patients being studied. This is also possible through contacting deputy of research and technology of the university.