Evaluation of the effect of intravenous vitamin C c in decreasing ferritin level in patients with ESRD under dialysis in Velayat hospital in Qazvin province in 2020
Design
This study was performed on 32 hemodialysis patients with inclusion criteria. Patients were randomly divided into intervention groups(A,N=16) and control groups(B,N=16) using Winpepi software.the study will be triple-blind.
Settings and conduct
This study is a clinical trial with the aim of determining the effect of intravenous vitamin C in decreasing ferritin level in patients with ESRD under dialysis in velayat hospital in Qazvin province in 2020.This study was performed on 32 patients with hemodialysis and inclusion criteria. ) And control B (N = 16) are divided. The study will be Triple-blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients undergoing hemodialysis with iron deficiency anemia with Hb <11 g / dl and serum ferritin level (> 500 ng / ml) and transferrin saturation (TSAT ≤ 20%)
Exclusion criteria:
1-Patients with infection. 2- Patients with inflammation. 3- Patients with a history of receiving venoffer in the last 2 months. 4- Patients who refuse to participate in the study. 5- Patients who do not seek treatment for any reason.
Intervention groups
Patients were randomly divided into intervention group A and control group B. Group A intravenous ascorbic acid 500 mg three times a week after each dialysis session for 3 months with erythropoietin and group B as much distilled water as placebo three times a week after each hemodialysis Erythropoietin IV is given by a colleague for 3 months.
Main outcome variables
Serum ferritin level,Hemoglobin,TIBC(Total Iron binding capacity ),Transferrin saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191112045426N1
Registration date:2020-01-07, 1398/10/17
Registration timing:prospective
Last update:2020-01-07, 1398/10/17
Update count:0
Registration date
2020-01-07, 1398/10/17
Registrant information
Name
Mohammad Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 1570
Email address
m.t.a.h.e.r.i@yandex.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-11, 1399/01/23
Expected recruitment end date
2020-05-12, 1399/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous vitamin c in decreasing ferritin level in patients with ESRD under dialysis
Public title
Effect of intravenous vitamin c in decreasing ferritin level in patients with ESRD under dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hemodialysis with iron deficiency anemia with Hb <11 g / dl and serum ferritin level (> 500 ng / ml) and transferrin saturation (TSAT ≤ 20%)
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling is done in an available way. Patients were randomly divided into intervention group A and control B using Winpepi software By a methodologist.
Blinding (investigator's opinion)
Triple blinded
Blinding description
As the intervention prescribed by the researchers is injected by the project executive, in addition to the patients who administer the intervention and evaluate the results, they are also blind to the type of intervention administered, so the study will be a triple-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2019-12-30, 1398/10/09
Ethics committee reference number
IR.QUMS.REC.1398.252
Health conditions studied
1
Description of health condition studied
Chronic kidney disease (CKD)
ICD-10 code
D63.1
ICD-10 code description
Anemia in chronic kidney disease
Primary outcomes
1
Description
Age
Timepoint
before intervention
Method of measurement
Form
2
Description
Gender
Timepoint
before intervention
Method of measurement
Form
3
Description
marital status
Timepoint
before intervention
Method of measurement
Form
4
Description
Serum ferritin level
Timepoint
before intervention and after three months
Method of measurement
Paraclinic
5
Description
Hemoglobin
Timepoint
before intervention and after three months
Method of measurement
Paraclinic
6
Description
TIBC(Total Iron binding capacity )
Timepoint
before intervention and after three months
Method of measurement
Paraclinic
7
Description
Transferrin saturation
Timepoint
before intervention and after three months
Method of measurement
Paraclinic
8
Description
Intervention group
Timepoint
before intervention and after three months
Method of measurement
software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received intravenous ascorbic acid 500 mg three times a week after each dialysis session for 3 months with erythropoietin IV.
Category
Treatment - Drugs
2
Description
Control group: The control group received distilled water as placebo three times a week after each hemodialysis for 3 months and erythropoietin IV.