Investigating the effect of melatonin supplementation on plasma level of Visfatin and insulin sensitivity on women with polycystic ovarian syndrome
Design
This is a phase 3 parallel double-blind randomized by random block method clinical trial study, with intervention and placebo groups, and 42 patients with polycystic ovary syndrome to evaluate the effect of melatonin supplementation on serum Visfatin and insulin sensitivity index for 8 weeks.
Settings and conduct
After obtaining a license from the Faculty of Nutrition, Tabriz University of Medical Sciences, patient selection will begin. The statistical population will be women with PCOS who referred to the gynecology clinic of Al-Zahra Hospital in Tabriz. The subject of the study and its importance will be explained to patients and the informed consent form will be provided to those who wish to cooperate. The eligibility form including anthropometric information will be completed, the melatonin intake will be assessed using the Melatonin Multiplicity Questionnaire. Fasting blood samples will be taken to assess levels of visfatin, fasting blood sugar, fasting insulin, and insulin sensitivity index. Patients will be randomly divided into two groups, using a random block table. For 8 weeks, every night Patients in the melatonin group will receive 6mg melatonin (2 tablets) (Nature Made, USA), and in the placebo group, 2 placeboes similar to melatonin, made by Tabriz School of Pharmacy. During the intervention, will be asked not to change diet and to report any changes.
Participants/Inclusion and exclusion criteria
Women 18 to 40 years old with polycystic ovary syndrome
Intervention groups
Melatonin intake by the intervention group, Placebo intake by the control group
Main outcome variables
Visfatin; insulin sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210224050490N1
Registration date:2021-05-08, 1400/02/18
Registration timing:registered_while_recruiting
Last update:2021-05-08, 1400/02/18
Update count:0
Registration date
2021-05-08, 1400/02/18
Registrant information
Name
Fakhrosadat Fayazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 3407
Email address
fayazif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-24, 1400/02/04
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of melatonin supplementation on plasma level of Visfatin and insulin sensitivity on women with polycystic ovarian syndrome
Public title
Melatonin in PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with PCOS
18-40 years old
BMI 20-40
Willingness to cooperate
Exclusion criteria:
Pregnancy
Lactation
Sleep disturbance
Shift work
Metabolic disease
Taking drugs that cause or affect the symptoms of polycystic ovary syndrome
Taking drugs that affect insulin sensitivity
Takeing antioxidant supplements
Following a special diet
Losing weight more than 5% of current weight in the last 6 months
Cigarettes and alcohol
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
For randomized allocation performing, permuted block randomization will be used by biohedral blocks. According to the sample size of 42 subjects, 21 blocks will be generated using the online site (www.sealedenvelope.com). Participants will be entered into the study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the receiving intervention type, as well as the random sequence which will be hidden and unpredictable.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, unique codes will be used on the medicine boxes. Melatonin and placebo tablets will be placed into the same appearance boxes by an independent third party. Participants will be entered into the study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, the participant and the researcher will be unaware of the type of treatment and the random sequence generated during the study will be unpredictable.
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
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2021-04-17, 1400/01/28
Ethics committee reference number
IR. TBZMED.REC. 1400.038
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Visfatin
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
ELISA kit
2
Description
Fasting blood sugar
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Spectrophotometry
3
Description
Insulin
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
ELISA kit
4
Description
Insulin sensitivity
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
The quantitative insulin-sensitivity check index formula (QUICKI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intake of 6 mg of melatonin (two tablets of 3 mg supplement of Nature Made, USA) one hour before bedtime, for 8 weeks.
Category
Treatment - Other
2
Description
Control group: Daily intake of two melatonin placebo (made by Pharmacy Faculty, Tabriz University of Medical Sciences) 1 hour before bed, for 8 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr Mohammad Alizadeh
Street address
South Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
info@alzahrahosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Samiei
Street address
Vice Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
mdalizadeh@tbzmed.ac.ir
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
Fakhrosadat Fayazi
Position
Msc student of clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3381 1902
Email
fayazif@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Alizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
mdalizadeh@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Alizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7313
Email
mdalizadeh@tbzmed.ac.ir
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