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A triple blinded randomized controlled trial of oral Melatonin in elevated blood pressure individuals

Protocol summary

Study aim
To evaluate the effects of melatonin or placebo on systolic and diastolic blood pressure , hs- CRP, IL-6, TNF-alpha and ICAM-1level, lipid profile , fasting blood sugar and sleeping pattern
Design
A two arms parallel group concealed randomized trial with triple blinding , phase three with 320 participants
Settings and conduct
Elevated blood pressure individuals will be assigned to intervention group of standardized diet for lowering blood pressure , exercise and 3 Mg Melatonin capsule versus control group receiving standardized diet for lowering blood pressure , exercise and placebo. Patients , medical providers and outcome evaluators are all blinded.Data analyzer and project evaluation committee will also be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals with systolic blood pressure120-129 or diastolic blood pressure =80mmHg, New cases, Age range of 30-60, Negative pregnancy test for women, Baseline melatonin and biomarkers level, liver function tests within normal range; Exclusion criteria: Previous history of hypersensitivity of melatonin, Past history of using antihypertensive treatment, hypertension, cardiovascular diseases, diabetes mellitus, and epilepsy, Use of beta-blockers, sleep aids, warfarin, flaxseed, soy and supplements
Intervention groups
Intervention group: Three weeks melatonin 3 Mg capsule one hour before bedtime along with a careful plan of heart-healthy diet, aerobic exercise of 5 times a week each time 30 minutes. Control group: Heart-healthy diet, aerobic exercise of 5 times a week each time 30 minutes and placebo capsule one time one hour before bedtime for three weeks.
Main outcome variables
Primary out comes: Change in systolic and diastolic blood pressure Change in lipid profile and inflammatory markers secondary outcomes: Change in sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181003041218N2
Registration date: 2019-01-05, 1397/10/15
Registration timing: registered_while_recruiting

Last update: 2019-01-05, 1397/10/15
Update count: 0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
zinat hatmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6405 3219
Email address
hatmizn@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A triple blinded randomized controlled trial of oral Melatonin in elevated blood pressure individuals
Public title
Melatonin in elevated blood pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic blood pressure 120-129 Diastolic blood pressure =80 mm Hg Age range of 30-60 years Negative pregnancy test for women at productive age Baseline Melatonin and biomarkers level and complete liver function tests within normal range
Exclusion criteria:
Past history of using antihypertensive treatment Past medical history of hypertension, cardiovascular diseases, (i.e. coronary artery disease), and diabetes mellitus, epilepsy Use of beta-blockers, sleep aids, warfarin, flaxseed and soy supplements Previous history of hypersensitivity of melatonin
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 320
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced randomization by using random blocks. Unit of randomization: Individual patients Randomization tool: Sealed envelope containing intervention group By using random block tables, 80 blocks of 4 members according to a total of 320 sample size will be chosen. Within each block there will be 2 interventions and 2 placebos. Permutations will be random and allocation to the study groups will be applied by using sealed envelope. Allocation concealment: Randomization will be assigned at the central office of design and performance of the trial. Patients and medical providers will be unaware of the randomization scheme and study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Triple blinding is planned. All participants, health care, data collectors and outcome assessors will be blinded about treatment arms. Data analyzer and person who is responsible for project monitoring will also be blinded. Blinding and assignment of interventional groups will be performed at central office of the trial and health care providers and outcome evaluators will be all blinded about the process. A Concealment envelope will assign patients to intervention group according to random block table. Melatonin and placebo capsule will be identical for keeping patients and medical providers blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Second floor, Building Number 1, Purcina Ave., Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2018-09-17, 1397/06/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.438

Health conditions studied

1

Description of health condition studied
Elevated blood pressure
ICD-10 code
I15
ICD-10 code description
Secondary hypertension

Primary outcomes

1

Description
Mean of systolic blood pressure change in mm Hg from baseline
Timepoint
Before intervention and 3 weeks later
Method of measurement
In clinic with standardized sphygmomanometer

2

Description
Mean of diastolic blood pressure change in mm Hg from baseline
Timepoint
Before intervention and 3 weeks later
Method of measurement
In clinic with standardized sphygmomanometer

3

Description
Mean cholesterol change in mg/dl from baseline
Timepoint
Before intervention and 3 weeks later
Method of measurement
Enzymatic laboratory method

4

Description
Mean low density lipoprotein change in mg/dl from baseline
Timepoint
Before intervention and 3 weeks later
Method of measurement
Enzymatic laboratory method

5

Description
Mean high sensitive CRP change in mg/l from baseline
Timepoint
Before intervention and 3 weeks later
Method of measurement
Laboratory method

Secondary outcomes

1

Description
ُChange in sleep quality score
Timepoint
Before intervention and 3 weeks later
Method of measurement
Pittsburg Sleep Quality inventory

Intervention groups

1

Description
Intervention group:Melatonin 3 mg oral capsule once one hour before bedtime for three weeks along with lifestyle intervention according to 2013 American heart association guideline. Melatonin capsules will made in Iran.
Category
Prevention

2

Description
Control group: oral placebo capsule once one hour before bedtime for three weeks along with lifestyle interventionaccording to 2013 American heart association guideline. Placebo capsules will made in Iran.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Out patient clinic medical faculties of Tehran University of Medical Sciences
Full name of responsible person
Zinat Hatmi
Street address
Second floor, Building Number 1, Purcina Ave, Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3319
Fax
+98 21 8802 9731
Email
info@thc.tums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Sahraiian
Street address
Sixth floor, Ghods Ave., Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6403 5220
Fax
+98 21 6405 3220
Email
info@sina.tums.ac.ir
Grant name
A triple blinded randomized controlled trial of oral Melatonin in elevated blood pressure individuals
Grant code / Reference number
38890
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Zinat Hatmi
Position
professor at TUMS
Latest degree
Specialist
Other areas of specialty/work
Cardioprevention
Street address
Second floor, Building Number 4, Purcina Ave, Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3220
Fax
+98 21 8896 2357
Email
znhatmi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zinat Hatmi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Cardioprevention
Street address
Second floor, Building Number 4, Purcina Ave, Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3220
Fax
+98 21 8896 2357
Email
znhatmi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zinat Hatmi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
Second floor, Building Number 4, Purcina Ave, Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3220
Fax
+98 21 8896 2357
Email
znhatmi@yahoo.com

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Just risk factors data without patients name
When the data will become available and for how long
After completing the final report and publication of the manuscript
To whom data/document is available
Authors who decides to write a systematic review
Under which criteria data/document could be used
Copy rights
From where data/document is obtainable
Published article
What processes are involved for a request to access data/document
Delivering a research proposal
Comments
Data will be published in the upcoming article
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