Protocol summary
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Study aim
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The aim of this study is to determine the effects of omega-3 fatty acids supplementation on treatment and metabolic profiles including insulin resistance and lipid profiles in patients with endometrial hyperplasia.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: 40 patients with endometrial hyperplasia of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with endometrial hyperplasia and aged 35 to 55 years will be included in this study. Exclusion criteria: Menopausal women, history of cardiovascular disease, hypertension, untreated thyroid disease, taking anti-inflammatory agents and Diabetes Mellitus.
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Intervention groups
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Intervention: Patients will be assigned to receive either omega-3 fatty acids (n=20) or placebo (n=20). Omega-3 fatty acids and placebos capsules are similar in shape and size.
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Main outcome variables
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Outcomes: Response to treatment and inflammatory markers (primary outcomes), and insulin metabolism parameters, lipid profiles and biomarkers of oxidative stress (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
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Reason for update
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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201701015623N98
Registration date:
2017-01-10, 1395/10/21
Registration timing:
retrospective
Last update:
2019-10-31, 1398/08/09
Update count:
1
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Registration date
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2017-01-10, 1395/10/21
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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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Vice chancellor for research, Arak University of Medical Sciences
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Expected recruitment start date
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2016-11-15, 1395/08/25
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Expected recruitment end date
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2016-12-15, 1395/09/25
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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 omega-3 fatty acids supplementation compared with the placebo on treatment and metabolic profiles in patients with endometrial hyperplasia
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Public title
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Effect of supplementation in treatment of patients with endometrial hyperplasia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged 35-55 years old
Patients with endometrial hyperplasia
Exclusion criteria:
Menopausal women
History of cardiovascular disease
Hypertension
Untreated thyroid disease
Taking anti-inflammatory agents
Diabetes Mellitus
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Age
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From 35 years old to 55 years old
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Gender
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Female
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Phase
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3
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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:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2016-11-14, 1395/08/24
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Ethics committee reference number
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IR.ARAKMU.REC.1395.310
Health conditions studied
1
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Description of health condition studied
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Endometrial hyperplasia
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ICD-10 code
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E11.2
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ICD-10 code description
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Endometrial hyperplasia
Primary outcomes
1
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Description
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Response to treatment
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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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Sonography
2
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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 kit
Secondary outcomes
1
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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
2
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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
3
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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
4
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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
5
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Description
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Total antioxidant
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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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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
7
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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
8
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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
9
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Description
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Fasting plasma glucose
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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
Intervention groups
1
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Description
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Inclusion criteria: Patients with endometrial hyperplasia; aged 30 to 50 years. Exclusion criteria: Unwillingness to cooperate.
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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), twice a day, for 12 weeks orally.
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Category
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Treatment - Drugs
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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Vice chancellor for research, Arak 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