Protocol summary
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Study aim
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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.
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Design
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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).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with Parkinson' disease; aged 50 to 90 years. Exclusion criteria: Unwillingness to cooperate.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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The revisions were accordance with the original approved proposal.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170513033941N29
Registration date:
2018-01-23, 1396/11/03
Registration timing:
registered_while_recruiting
Last update:
2020-05-14, 1399/02/25
Update count:
2
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Registration date
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2018-01-23, 1396/11/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-02, 1396/10/12
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Expected recruitment end date
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2018-02-01, 1396/11/12
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of melatonin supplementation in treatment of patients with Parkinson's disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Patients with Parkinson' disease.
Individuals aged 50 to 90 years.
Exclusion criteria:
Exclusion criteria: Unwillingness to cooperate
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Age
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From 50 years old to 90 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-01, 1396/10/11
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.93
Health conditions studied
1
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Description of health condition studied
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Parkinson's disease
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ICD-10 code
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G20
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ICD-10 code description
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Parkinson's disease
Primary outcomes
1
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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ELISA test
Secondary outcomes
1
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Description
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UPDRS
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Physical Examination by Neurologist
2
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
3
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
4
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
7
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
8
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
9
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
10
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Description
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HDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
11
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Description
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Expressed levels of TNF-a gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
12
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Description
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Expressed levels of IL-8 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
13
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Description
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Expressed levels of TGF-β gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
14
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Description
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Expressed levels of PPAR-γ gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
15
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Description
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Expressed levels of LDL-R gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
16
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Description
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PSQI
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questioner
17
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Description
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BAI
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questioner
18
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Description
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BDI
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questioner
Intervention groups
1
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Description
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Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available