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Effect of nigella sativa oil supplementation on kidney function tests, glycemic parameters, lipid profile, oxidative stress, inflammation, quality of life, and depression status in diabetic hemodialysis patients

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History
# Registration date Revision Id
2 2021-12-05, 1400/09/14 208115
1 2020-05-31, 1399/03/11 136711
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  • General information

    empty
    In the first loading of content, a number of important and influential variables as a result of the study were mistakenly written in the secondary variables section; Therefore, in this form of correction, they were transferred to the primary variables. It was also forgotten that cholesterol and triglycerides were included in the variables, which were also included in the initial variables in their correction. Due to the fact that the nutritional status of patients could be a confounder, so the amount of energy and macronutrients consumed were included in our design as a secondary variable.
    empty
    در مرتبه اول بارگذاری محتوا، به اشتباه تعدادی از متغیر های مهم و اثر گذار در نتیجه مطالعه، در قسمت متغیر های ثانویه نوشته شده بودند؛ لذا در این فرم اصلاحیه، آنها به قسمت متغیر های اولیه انتقال پیدا کردند. همچنین فراموش شده بود که کلسترول و تریگلیسرید در متغیر ها وارد شوند که در اصلاحیه آن ها نیز وارد متغیر های اولیه شدند. با توجه به این که وضعیت تغذیه بیماران میتوانست یک مخدوشگر باشد لذا میزان انرژی و درشت مغذی مصرفی نیز به عنوان متغیر ثانویه وارد طرح مان شدند.
    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
    Effect of nigella sativa oil supplementation on kidney function tests, glycemic parameters, lipid profile, oxidative stress, inflammation, quality of life, and depression status in diabetic hemodialysis patients
    تأثیر مکمل‌یاری روغن سیاه‌دانه بر شاخص‌های عملکرد کلیه، شاخص‌های قند خون، استرس اکسیداتیو، وضعیت التهاب، کیفیت زندگی و افسردگی در بیماران مبتلا به دیابت تحت درمان با همودیالیز
    تأثیر مکمل‌یاری روغن سیاه‌دانه بر شاخص‌های عملکرد کلیه، شاخص‌های قند خون، پروفایل لیپیدی، استرس اکسیداتیو، وضعیت التهاب، کیفیت زندگی و افسردگی در بیماران مبتلا به دیابت تحت درمان با همودیالیز
    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
    Age: 18-60
    BMI: 18.5-30
    Diabetes
    At least 6 months of dialysis history
    maximum 10 years of dialysis history
    Ability and willingness to cooperate
    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
    Background diseases (heart failure stage 3 and 4, acute liver and thyroid disease, malignancy)
    nigella sativa oil consumption before entering the study
    Alcohol addiction, smoking
    receiving steroidal or nonsteroidal anti-inflammatory drugs
    sever reaction to supplement or placebo

  • Primary outcomes

    #1
    HbA1c
    Glycated hemoglobin (HbA1c)
    #2
    AlGl
    glycated albumin (AlGl)
    #3
    MDA
    Malondialdehyde (MDA)
    سوپراکسید دیسموتاز
    به روش اسپکتروفتومتری
    #4
    SOD
    superoxide dismutase (SOD)
    #5
    TAC
    total antioxidant capacity (TAC)
    #6
    hs-CRP
    High-sensitivity C-reactive protein (hs-CRP)
    #7
    empty
    Urine volume
    empty
    حجم ادرار
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Through the urine within 24 hours
    empty
    از طریق ظرف ادرار 24 ساعته
    #8
    empty
    insulin
    empty
    انسولین
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Eliza's method
    empty
    به روش الایزا
    #9
    empty
    Hospital Anxiety and Depression Scale (HADS) questionnaire
    empty
    پرسشنامه مقیاس اضطراب و افسردگی بیمارستان
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Information on the questionnaire will be obtained from patients before and after treatment
    empty
    اطلاعات مربوط به پرسشنامه مذکور قبل و بعد مداخله درمانی، از بیماران گرفته خواهد شد
    #10
    empty
    Kidney Disease Quality of Life (KDQOL) questionnaire
    empty
    پرسشنامه کیفیت زندگی بیماران کلیوی
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Information on the questionnaire will be obtained from patients before and after treatment
    empty
    اطلاعات مربوط به پرسشنامه مذکور قبل و بعد مداخله درمانی، از بیماران گرفته خواهد شد
    #11
    empty
    uric acid
    empty
    اسید اوریک
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Spectrophotometric method
    empty
    روش اسپکتروفتومتری
    #12
    empty
    High-density lipoprotein (HDL)
    empty
    لیپوپروتئین با دانسیته بالا (کلسترول خوب)
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Spectrophotometric method
    empty
    روش اسپکتروفتومتری
    #13
    empty
    Low-density lipoprotein (LDL)
    empty
    لیپوپروتئین با دانسیته کم (کلسترول بد)
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Spectrophotometric method
    empty
    روش اسپکتروفتومتری

  • Secondary outcomes

    #1
    FBS
    Energy consumption
    قند ناشتا
    انرژی مصرفی
    قبل و بعد از شروع مطالعه
    Before starting the study
    Before baseline and after study
    قبل از شروع مطالعه
    enzymatic method
    24-h Questionnaire
    به روش آنزیمی
    پرسشنامه 24 ساعته
    #2
    حجم ادرار
    Macronutrient consumption
    Urine volume
    درشت مغذی مصرفی
    Before baseline and after study
    Before starting the study
    قبل و بعد از شروع مطالعه
    قبل از شروع مطالعه
    Through the urine within 24 hours
    24-h Questionnaire
    از طریق ظرف 24 ساعته ادرار
    پرسشنامه 24 ساعته
    #3
    insulin
    empty
    انسولین
    empty
    Before baseline and after study
    empty
    قبل و بعد از شروع مطالعه
    empty
    Eliza's method
    empty
    روش الایزا
    empty
    #4
    HADS questionnair
    empty
    پرسشنامه HADS
    empty
    Before baseline and after study
    empty
    قبل و بعد از شروع مطالعه
    empty
    Information on the questionnaire will be obtained from patients before and after treatment
    empty
    اطلاعات مربوط به پرسشنامه مذکور قبل و بعد مداخله درمانی، از بیماران گرفته خواهد شد
    empty
    #5
    KDQOL questionnair
    empty
    پرسشنامه KDQOL
    empty
    Before baseline and after study
    empty
    قبل و بعد از شروع مطالعه
    empty
    Information on the questionnaire will be obtained from patients before and after treatment
    empty
    اطلاعات مربوط به پرسشنامه مذکور قبل و بعد مداخله درمانی، از بیماران گرفته خواهد شد
    empty
    #6
    uric acid
    empty
    اسید اوریک
    empty
    Before baseline and after study
    empty
    قبل از شروع مطالعه و بعد از اتمام مطالعه
    empty
    Spectrophotometric method
    empty
    به روش اسپکتروفتومتری
    empty

Protocol summary

Study aim
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
In the first loading of content, a number of important and influential variables as a result of the study were mistakenly written in the secondary variables section; Therefore, in this form of correction, they were transferred to the primary variables. It was also forgotten that cholesterol and triglycerides were included in the variables, which were also included in the initial variables in their correction. Due to the fact that the nutritional status of patients could be a confounder, so the amount of energy and macronutrients consumed were included in our design as a secondary variable.
Acronym
IRCT registration information
IRCT registration number: IRCT20200411047027N1
Registration date: 2020-05-31, 1399/03/11
Registration timing: registered_while_recruiting

Last update: 2021-12-06, 1400/09/15
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, lipid profile, oxidative stress, inflammation, 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 Diabetes 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 consumption 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
Glycated hemoglobin (HbA1c)
Timepoint
Before baseline and after study
Method of measurement
High-performance liquid chromatography (HPLC)

4

Description
glycated albumin (AlGl)
Timepoint
Before baseline and after study
Method of measurement
Enzymatic method

5

Description
Malondialdehyde (MDA)
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method

6

Description
superoxide dismutase (SOD)
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method

7

Description
total antioxidant capacity (TAC)
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method

8

Description
High-sensitivity C-reactive protein (hs-CRP)
Timepoint
Before baseline and after study
Method of measurement
Turbidimetry

9

Description
Urine volume
Timepoint
Before baseline and after study
Method of measurement
Through the urine within 24 hours

10

Description
insulin
Timepoint
Before baseline and after study
Method of measurement
Eliza's method

11

Description
Hospital Anxiety and Depression Scale (HADS) questionnaire
Timepoint
Before baseline and after study
Method of measurement
Information on the questionnaire will be obtained from patients before and after treatment

12

Description
Kidney Disease Quality of Life (KDQOL) questionnaire
Timepoint
Before baseline and after study
Method of measurement
Information on the questionnaire will be obtained from patients before and after treatment

13

Description
uric acid
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method

14

Description
High-density lipoprotein (HDL)
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method

15

Description
Low-density lipoprotein (LDL)
Timepoint
Before baseline and after study
Method of measurement
Spectrophotometric method

Secondary outcomes

1

Description
Energy consumption
Timepoint
Before starting the study
Method of measurement
24-h Questionnaire

2

Description
Macronutrient consumption
Timepoint
Before starting the study
Method of measurement
24-h Questionnaire

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
sending an e-mail to : a74.rahmani@gmail.com
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