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Investigation of the effect of melatonin on the lipid levels in menopausal woman attending in selected Gynecology Clinics of Shiraz University of medical sciences, 1391

Protocol summary

Summary
The aim of this study was to investigate the effect of melatonin on lipid levels in healthy postmenopausal women. The study was designed as a randomized, double-blind, controlled clinical trial. 240 healthy postmenopausal women aged 60-40 referred to selected clinics enrolled to this study. In the intervention group (A), 120 women received melatonin tablets (3mg every night: 6-9 P.M) and, in the control group, 120 women received the placebo (Avicel) for 3 months. Key inclusion criteria were cessation of the menstrual cycle for at least 6 months and FSH above 40 IU. Exclusion criteria were a history of active liver, kidney, heart, thyroid, diabetes, and inflammatory diseases, hormone therapy for at least during last 6 months, and showing allergic reaction to the drug. Venous blood samples were taken from volunteers to determine the lipid status including values of LDL, HDL, TG and Cholesterol before intervention and three months after the intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012090810774N1
Registration date: 2016-05-08, 1395/02/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Nehleh Parandavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 3686
Email address
parandavar@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-09-20, 1392/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of melatonin on the lipid levels in menopausal woman attending in selected Gynecology Clinics of Shiraz University of medical sciences, 1391
Public title
The effect of melatonin on the lipid levels
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria of the study: having general health based on the Goldberg’s questionnaire (achieving score less than 23); married women between 40 to 60 years old; not using vitamin supplements; not having used hormone therapy during the last 3 months; complete physical health in physical examinations; cessation of the menstrual cycle for at least 6 months; and FSH above 40 IU. The exclusion criteria of the study: A history of active liver, kidney, heart, thyroid, diabetes and inflammatory diseases; inability to continue drug use for any reason; unwillingness to continue participation in the study; and showing allergic reaction to the drug. In addition, if any of the conditions listed in the inclusion criteria were violated at any time, the volunteer would be excluded from the study.
Age
From 40 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2012-12-23, 1391/10/03
Ethics committee reference number
6384-91

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause

Primary outcomes

1

Description
Serum lipid
Timepoint
Before intervention,3 month after intervention
Method of measurement
Lipid of plasma were measured based on the international units.

Secondary outcomes

1

Description
Changes in body mass index
Timepoint
Before intervention,3 month after intervention
Method of measurement
Dividing weight in kilograms by the square of height in meters

Intervention groups

1

Description
Intervention group: 3 milligram tablets of melatonin every night between 6 and 9 P.M. for 3 months
Category
Treatment - Drugs

2

Description
Control group: 3 milligram tablets of placebo of melatonin every night between 6 and 9 P.M. for 3 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari Clinic
Full name of responsible person
Khadijeh Abdali
Street address
Namazi square, Motahhari Clinic, Obstetrics and gynecology ward
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellery of research,Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery of research,Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Abdali
Position
Master's degree in Midwifery
Other areas of specialty/work
Street address
Namazi square, Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
Abdalikh@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Khadijeh Abdali
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq. Fatemeh (PBUH) College of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
abdalikh@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Nehleh Parandavar
Position
Master's degree in Midwifery
Other areas of specialty/work
Street address
Namazi Sq. Fatemeh (PBUH) College of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
parandavar@jums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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