Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of combined magnesium and vitamin E supplementation on metabolic profiles in patients with polycystic ovary syndrome (PCOS).
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Design
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at Kosar outpatient 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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Settings and conduct
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Among patients with polycystic ovary syndrome referred to Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: The intake of magnesium and vitamin E supplements within the past 3 months and metabolic disorders.
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Intervention groups
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Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, Iran) daily for 12 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
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Main outcome variables
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Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profile (secondary outcomes) will be quantified at study baseline and end-of-trial.
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:
IRCT2017090133941N18
Registration date:
2017-10-29, 1396/08/07
Registration timing:
registered_while_recruiting
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2017-10-29, 1396/08/07
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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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2017-10-16, 1396/07/24
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Expected recruitment end date
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2017-10-30, 1396/08/08
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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 combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome
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Public title
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Effect of combined magnesium and vitamin E 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 aged 18 to 40 years
Exclusion criteria:
The intake of magnesium and vitamin E supplements within the past 3 months
Metabolic disorders
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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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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:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, after balanced blocked randomisation, all participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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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 Kosar outpatient 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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2017-10-15, 1396/07/23
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Ethics committee reference number
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IR.ARAKMU.REC.1396.120
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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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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Insulin resistance
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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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Calculation using HOMA formula
Secondary outcomes
1
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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
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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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
4
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Description
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LDL
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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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FPG
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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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Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, Iran) daily 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 capsule (Barij Essence, Kashan, Iran), daily 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