Effect of nigella sativa oil supplementation on kidney function tests, glycemic parameters, oxidative stress, inflamation, quality of life and depression status in diabetic hemodialysis patients
determination of the Effect of Nigella Sativa oil supplementation on kidney function tests, glycemic parameters, oxidative stress, inflammation, quality of life and depression status in diabetic hemodialysis patients
Design
A clinical trial with control group, two groups of parallel, double-blind, Phase 3, on 46 hemodialysis patients, randomization using RAS software
Settings and conduct
This study will be conducted in the dialysis department of Imam Reza Hospital in Tabriz.
The supplement and Placebo are produced in a completely similar way in terms of shape, color, and smell. supplements will be given to researchers and patients in a same and sealed cans. both patients and researchers are blind ton this Process.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
diabetic patients undergoing hemodialysis
At least 6 months of hemodialysis his
Maximum 10 years of hemodialysis history
BMI between 18.5 to 30
inclusion criteria :
Smoking and alcohol-abusing
use of corticosteroids and NSAIDs
Severe underlying diseases (stage 3 and 4 heart failure, acute liver and thyroid disease, malignancy)
Intervention groups
The intervention group will receive 2 capsules of 1000 mg of black seed oil (with lunch and dinner). the placebo group will take 2 capsules of 1000 mg of paraffin of cellulose for 12 weeks.
Main outcome variables
Laboratory tests including:
renal function tests as creatinine, urea, uric acid, urine volume
indices related to blood glucose including fasting blood sugar, HbA1c, glycosylated albumin (AlGl)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047027N1
Registration date:2020-05-31, 1399/03/11
Registration timing:registered_while_recruiting
Last update:2020-05-31, 1399/03/11
Update count:1
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
alireza rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7736 4020
Email address
a74.rahmani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nigella sativa oil supplementation on kidney function tests, glycemic parameters, oxidative stress, inflamation, quality of life and depression status in diabetic hemodialysis patients
Public title
nigella sativa in hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-60
BMI: 18.5-30
Daibetes
At least 6 months of dialysis history
maximum 10 years of dialysis history
Ability and willingness to cooperate
Exclusion criteria:
Background diseases (heart failure stage 3 and 4, acute liver and thyroid disease, malignancy)
nigella sativa oil consumtion before entering the study
Alcohol addiction, smoking
receiving steroidal or nonsteroidal anti-inflammatory drugs
sever reaction to supplement or placebo
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly allocated to either a Nigella Sativa oil or control group by block randomization after stratification based on the frequency of hemodialysis per week (2 or 3 times per week) and the amount of blood sugar (blood glucose below 120, blood sugar between 120-200 and blood sugar above 200). This process is carried by a Statistics Specialist using RAS (Random allocation software) and in block sizes of 4. the sample size of each group is 23 people.
A trained dietician will perform blinding, and the patients and researchers will be kept blinded to the allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
A total of 46 ESRD patients with ESRD selected by the inclusion criteria. after explaining the objectives of the study, and obtaining written consent, they will be entered into the study.
Subjects are randomly divided into two groups of intervention and control. The supplements will be available to attendees every two weeks. Each patient should consume 2 capsules daily. The supplement and Placebo are produced in a completely similar way in terms of shape, color, and smell and in sealed cans.
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
attar ave
City
tabriz
Province
East Azarbaijan
Postal code
1653666741
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.TBZMED.REC.1399.109
Health conditions studied
1
Description of health condition studied
Diabetic patients undergoing hemodialysis
ICD-10 code
E00–E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
urea
Timepoint
Before baseline and after study
Method of measurement
Chemical method
2
Description
creatinine
Timepoint
Before baseline and after study
Method of measurement
jaffe method
3
Description
HbA1c
Timepoint
Before baseline and after study
Method of measurement
High-performance liquid chromatography (HPLC)
4
Description
AlGl
Timepoint
Before baseline and after study
Method of measurement
Enzymatic method
5
Description
MDA
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method
6
Description
SOD
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method
7
Description
TAC
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method
8
Description
hs-CRP
Timepoint
Before baseline and after study
Method of measurement
Turbidimetry
Secondary outcomes
1
Description
FBS
Timepoint
قبل و بعد از شروع مطالعه
Method of measurement
enzymatic method
2
Description
حجم ادرار
Timepoint
Before baseline and after study
Method of measurement
Through the urine within 24 hours
3
Description
insulin
Timepoint
Before baseline and after study
Method of measurement
Eliza's method
4
Description
HADS questionnair
Timepoint
Before baseline and after study
Method of measurement
Information on the questionnaire will be obtained from patients before and after treatment
5
Description
KDQOL questionnair
Timepoint
Before baseline and after study
Method of measurement
Information on the questionnaire will be obtained from patients before and after treatment
6
Description
uric acid
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method
Intervention groups
1
Description
Intervention group: The intervention group will receive 2 capsules of 1000 mg of black seed oil (with lunch and dinner) for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: the placebo group will take 2 capsules of 1000 mg of paraffin of cellulose for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
hemodialysis center of imam reza hospital
Full name of responsible person
ali tarighat esphanjani
Street address
attar neishbori
City
tabriz
Province
East Azarbaijan
Postal code
1653666741
Phone
+98 21 7736 4020
Email
a74.rahmani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ali tarighat esphanjani
Street address
attar ave.
City
tabriz
Province
East Azarbaijan
Postal code
1653666741
Phone
+98 21 7736 4020
Email
a74.rahmani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ali tarighat esphanjani
Position
Associate Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
attar ave.
City
tabriz
Province
East Azarbaijan
Postal code
1653666741
Phone
+98 21 7736 4020
Email
a74.rahmani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ali tarighat esphanjani
Position
Associate Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
attar ave
City
tabriz
Province
East Azarbaijan
Postal code
1653666741
Phone
+98 21 7736 4020
Email
a74.rahmani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
alireza rahmani
Position
master of sience students
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
attar ave
City
tabriz
Province
East Azarbaijan
Postal code
1653666741
Phone
+98 21 7736 4020
Email
a74.rahmani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
My protocol will be shared
When the data will become available and for how long
beginning of 2021
To whom data/document is available
Dr Ali Trighat esphanjani
Under which criteria data/document could be used
Edit For analytical and epidemiological studies
From where data/document is obtainable
email :
a74.rahmani@gmail.com
What processes are involved for a request to access data/document