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Clinical trial of the effect of melatonin supplementation compared with the placebo on clinical status, metabolic profiles and gene expression related to inflammation, insulin and lipid in patients with Parkinson's disease

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History
# Registration date Revision Id
3 2020-05-09, 1399/02/20 134282
2 2019-05-08, 1398/02/18 89539
1 2018-01-23, 1396/11/03 34293
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  • Protocol summary

    Outcomes: BIomarkers of oxidative stress (primary outcomes) and inflammatory factors, lipid profile, markers of insulin metabolism and gene expression related to insulin, lipid and inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial.
    Outcomes: Hs-CRP (primary outcome) and UPDRS, biomarkers of oxidative stress, lipid profile, markers of insulin metabolism and gene expression related to insulin, lipid and inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial.
    پيامدها: بیومارکرهای استرس اکسیداتیو و علایم بالینی (پیامدهای اولیه) و فاکتورهای التهابی و لیپید پروفایل و مارکرهای متابولیسم انسولین و بیان ژن مرتبط با انسولین، لیپید و التهاب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
    پيامدها: hs-CRP (پیامد اولیه) و UPDRS، بیومارکرهای استرس اکسیداتیو و لیپید پروفایل و مارکرهای متابولیسم انسولین و بیان ژن مرتبط با انسولین، لیپید و التهاب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • Primary outcomes

    #1
    UPDRS
    Hs-CRP
    UPDRS
    پروتئین واکنشگر C با حساسیت بالا
    Physical Examination by Neurologist
    ELISA test
    معاینه فیزیکی توسط متخصص اعصاب
    کیت الایزا
    #2
    Malondialdehyde
    empty
    مالون دی آلدئید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #3
    Glutathione
    empty
    گلوتاتیون
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #4
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty

  • Secondary outcomes

    #1
    Hs-CRP
    UPDRS
    پروتئین واکنشگر C با حساسیت بالا
    UPDRS
    Elisa kit
    Physical Examination by Neurologist
    کیت الایزا
    معاینه فیزیکی توسط متخصص اعصاب
    #2
    Nitric oxide
    Malondialdehyde
    نیتریک اکساید
    مالون دی آلدئید
    #3
    Insulin
    Glutathione
    انسولین
    گلوتاتیون
    Elisa kit
    Spectrophotometry
    کیت الایزا
    اسپکتروفتومتری
    #4
    Insulin resistance
    Total antioxidant capacity
    مقاومت به انسولین
    ظرفیت آنتی اکسیدانی توتال
    Calculation using HOMA formula
    Spectrophotometry
    محاسبه با استفاده از فرمول HOMA
    اسپکتروفتومتری
    #5
    Triglycerides
    Nitric oxide
    تری گلیسرید
    نیتریک اکساید
    Enzymatic kit
    Spectrophotometry
    کیت آنزیمی
    اسپکتروفتومتری
    #6
    Total cholesterol
    Insulin
    توتال کلسترول
    انسولین
    Enzymatic kit
    Elisa kit
    کیت آنزیمی
    کیت الایزا
    #7
    HDL
    Insulin resistance
    HDL
    مقاومت به انسولین
    Enzymatic kit
    Calculation using HOMA formula
    کیت آنزیمی
    محاسبه با استفاده از فرمول HOMA
    #8
    Expressed levels of TNF-a gene
    Triglycerides
    سطوح بیان TNF-a
    تری گلیسرید
    PCR
    Enzymatic kit
    PCR
    کیت آنزیمی
    #9
    Expressed levels of IL-1 gene
    Total cholesterol
    سطوح بیان IL-1
    توتال کلسترول
    PCR
    Enzymatic kit
    PCR
    کیت آنزیمی
    #10
    xpressed levels of IL-8 gene
    HDL
    سطوح بیان IL-8
    HDL
    PCR
    Enzymatic kit
    PCR
    کیت آنزیمی
    #11
    Expressed levels of PPAR-γ gene
    Expressed levels of TNF-a gene
    سطوح بیان PPAR-γ
    سطوح بیان TNF-a
    #12
    Expressed levels of Ox-LDL gene
    Expressed levels of IL-8 gene
    سطوح بیان Ox-LDL
    سطوح بیان IL-8
    #13
    empty
    Expressed levels of TGF-β gene
    empty
    سطوح بیان TGF-β
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    PCR
    empty
    PCR
    #14
    empty
    Expressed levels of PPAR-γ gene
    empty
    سطوح بیان PPAR-γ
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    PCR
    empty
    PCR
    #15
    empty
    Expressed levels of LDL-R gene
    empty
    سطوح بیان ژن LDR-R
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    PCR
    empty
    PCR

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of melatonin supplementation on clinical status, metabolic profiles and gene expression related to inflammation, insulin and lipid in patients with Parkinson's disease.
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive melatonin supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with Parkinson's disease referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Parkinson' disease; aged 50 to 90 years. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally.
Main outcome variables
Outcomes: Hs-CRP (primary outcome) and UPDRS, biomarkers of oxidative stress, lipid profile, markers of insulin metabolism and gene expression related to insulin, lipid and inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170513033941N29
Registration date: 2018-01-23, 1396/11/03
Registration timing: registered_while_recruiting

Last update: 2019-05-10, 1398/02/20
Update count: 2
Registration date
2018-01-23, 1396/11/03
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-02, 1396/10/12
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of melatonin supplementation compared with the placebo on clinical status, metabolic profiles and gene expression related to inflammation, insulin and lipid in patients with Parkinson's disease
Public title
Effect of melatonin supplementation in treatment of patients with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with Parkinson' disease. Individuals aged 50 to 90 years.
Exclusion criteria:
Exclusion criteria: Unwillingness to cooperate
Age
From 50 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.93

Health conditions studied

1

Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA test

Secondary outcomes

1

Description
UPDRS
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Physical Examination by Neurologist

2

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

3

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

4

Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

6

Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

7

Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula

8

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

9

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

10

Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

11

Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR

12

Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR

13

Description
Expressed levels of TGF-β gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR

14

Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR

15

Description
Expressed levels of LDL-R gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR

Intervention groups

1

Description
Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
asemi_z@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
asemi_z@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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