The relationship between serum levels of total antioxidants and vitamin D supplementation will be evaluated in Hemodialysis Patients.
Design
86 dialysis patients will be included in the phase 3 of study via simple random non-probability sampling method consecutively. After that patients will randomly be divided into two similar parallel, double-blind groups of Colecalciferol and Placebo with random digits table. All data will remain private with encoding method.
Settings and conduct
In this clinical trial study, 86 dialysis patients who referred to Hemodialysis center of Tabriz university of medical sciences were randomly divided into two groups and one group will be receiving Colecalciferol and the other group receiving Placebo. The two groups will be in almost the same range in terms of diet and activity. All names and personal data of patients will encode during gathering data and will remain totally private. In addition, none of the participants will be grouped at the beginning of study.
Participants/Inclusion and exclusion criteria
Including criteria: Consent to participate in the study; Age range of 15-70 years; Dialysis patients undergoing blood dialysis for more than 3 months; Patients undergoing hemodialysis 3 times a week; Patients undergoing blood hemodialysis that their 25-hydroxyvitamin D concentration is less than 30 ng/ml.
Excluding criteria: Dissatisfaction to participate in the study; Patients with active infection; Patients with history of renal transplantation; Patients with any history of malignancy; Presence of hyperphosphatemia (Blood phosphor >7); History of parathyroidectom
Intervention groups
Intervention group: Colecalciferol (50000 units per week for 12 weeks; Control group: Placebo
Main outcome variables
Evaluation of lipid profile, serum levels of 25OHD, Hemoglobin, PTH, Calcium, Phosphor, Klotho, ,MDA, CRP, and routine laboratory factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049311N3
Registration date:2021-02-06, 1399/11/18
Registration timing:registered_while_recruiting
Last update:2021-02-06, 1399/11/18
Update count:0
Registration date
2021-02-06, 1399/11/18
Registrant information
Name
Seyyedeh Mina Hejazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
smhjz.biotech@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-30, 1399/10/10
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the relationship between Serum Levels of Total Antioxidants and Vitamin D supplementation in Hemodialysis Patients
Public title
Evaluation of the relationship between Serum Levels of Total Antioxidants and Vitamin D supplementation in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Age range of 15-70 years
Dialysis patients undergoing blood dialysis for more than 3 months.
Patients undergoing hemodialysis 3 times a week.
Patients undergoing blood hemodialysis that their 25-hydroxyvitamin D concentration is less than 30 ng/ml.
Exclusion criteria:
Dissatisfaction to participate in the study
Patients with active infection
Patients with history of renal transplantation
Patients with any history of malignancy
Presence of hyperphosphatemia (Blood phosphor >7)
History of parathyroidectomy
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be by blocking method and groups division will be perform with an equal number of patients individually. Patients will divided by random digit table. Thus, the statistical population and sample size will be determined first and they will be respectively given a code or serial number. Then, the entered codes will be selected randomly from the table. This study will be double-blinded and all participants and individuals evaluating consequences of the intervention will be unaware from the allocation of study groups. Randomly allocation concealment will also go on with the method of not determining study groups before selecting patients and included individuals will be randomly grouped after sampling in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
En All names and personal data of patients will encode during gathering data and will remain totally private. In addition, none of the participants will be grouped at the beginning of study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences, Golgasht St, Tabriz