Protocol summary
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Study aim
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The aim of this study is to determine the effects of carnitine supplementation on carotid intima-media thickness (CIMT) and biomarkers of inflammation in women with polycystic ovary syndrome.
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Design
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Parallel double-blind (both patients and researchers) clinical trial
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Settings and conduct
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Among patients with polycystic ovary syndrome referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
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Participants/Inclusion and exclusion criteria
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Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, elevated levels of prolactin, and endocrine diseases.
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Intervention groups
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Patients will be assigned to receive either carnitine (n=30) or placebo (n=30).
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Main outcome variables
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Carotid intima-media thickness (primary outcome) and biomarkers of inflammation (secondary outcomes)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017070433941N3
Registration date:
2017-07-31, 1396/05/09
Registration timing:
retrospective
Last update:
2019-09-24, 1398/07/02
Update count:
1
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Registration date
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2017-07-31, 1396/05/09
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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, Kashan University of Medical Sciences
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Expected recruitment start date
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2016-07-11, 1395/04/21
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Expected recruitment end date
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2016-08-11, 1395/05/21
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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 carnitine supplementation compared with the placebo on carotid intima-media thickness and biomarkers of inflammation in women with polycystic ovary syndrome
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Public title
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Effect of carnitine supplementation in treatment of women with polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with polycystic ovary syndrome according to Rotterdam criteria
Aged 18 to 40 years
Exclusion criteria:
Pregnant women
Elevated levels of prolactin
Endocrine diseases
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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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 balanced blocked randomization, subjects will be randomly divided into two groups to take either carnitine supplements (n = 30) or placebo (n =30). 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 at the Naghavi Clinic, 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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2016-07-10, 1395/04/20
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Ethics committee reference number
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IR.KAUMS.REC.1395.21
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Mean left CIMT
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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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Maximum left CIMT
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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
3
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Description
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Mean right CIMT
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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
4
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Description
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Maximum right CIMT
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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
Secondary 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 kit
2
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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
Intervention groups
1
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Description
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Intervention group: 250 mg carnitine (Avecina, Tehran, Iran), once a day, 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), once 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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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