Protocol summary
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Study aim
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The aim of this study is to determine the effects of chromium supplementation on metabolic profiles in patients of polycystic ovary syndrome of IVF candidate.
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Design
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Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive chromium supplements (n=20) or placebo (n=20).
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Settings and conduct
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Among patients with polycystic ovary syndrome candidate for IVF referred to Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 40 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 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criterion: Androgen-secreting tumors, thyroid dysfunction, diabetes or impaired glucose tolerance.
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Intervention groups
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Intervention group: Chromium supplements (Nature Made, California, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally.
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Main outcome variables
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Outcomes: Glycemic control (primary outcomes) and lipid profiles and biomarkers of inflammation and oxidative stress (secondary outcome) 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:
IRCT201706075623N120
Registration date:
2017-06-22, 1396/04/01
Registration timing:
retrospective
Last update:
2019-09-11, 1398/06/20
Update count:
1
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Registration date
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2017-06-22, 1396/04/01
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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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2017-05-23, 1396/03/02
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Expected recruitment end date
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2017-06-10, 1396/03/20
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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 chromium supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome of IVF candidate
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Public title
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Effect of supplementation in treatment of women with polycystic ovary syndrome of IVF candidate
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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
Individuals aged 18 to 40 years old
Exclusion criteria:
Androgen-secreting tumors
Thyroid dysfunction
Diabetes or impaired glucose tolerance
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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:
40
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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, after ratification based on age and BMI, subjects will be randomly allocated into two groups to receive supplements or placebo. 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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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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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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Randomization will be done by the use of computer-generated random numbers.
Ethics committees
1
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Ethics committee
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Approval date
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2017-05-22, 1396/03/01
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Ethics committee reference number
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IR.ARAKMU.REC.1396.50
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian 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 8 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 8 weeks of intervention
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Method of measurement
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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 8 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 8 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-cholesterol
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Timepoint
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At the beginning of the study and after 8 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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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Total glutathione
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Timepoint
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At the beginning of the study and after 8 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 8 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: Chromium supplements (Nature Made, California, USA), 200 µg, daily, for 8 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 8 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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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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Private
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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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable