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 zinc supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
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Design
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Study design: Randomized double-blind placebo-controlled trial, All participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two groups. Randomization will be done by the use of computer software.
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Settings and conduct
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Among patients with polycystic ovary syndrome referred to Naghavi outpatient Clinic affiliated to Kashan 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: Individuals with androgen-secreting tumors, CVD and diabetes, thyroid dysfunction, and pregnant women.
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Intervention groups
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Intervention group: 250 mg magnesium oxide (21st Century, Arizona, USA) + 220 mg of zinc sulfate (Alhavi Pharmaceutical Company, Tehran, Iran) daily, for 12 weeks orally. Control group: Placebo, 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 profiles and gene expression related to insulin and lipid (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:
IRCT20170513033941N40
Registration date:
2018-10-31, 1397/08/09
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2018-10-31, 1397/08/09
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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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Expected recruitment start date
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2018-07-31, 1397/05/09
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Expected recruitment end date
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2018-08-15, 1397/05/24
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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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The effects of combined zinc and magnesium supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
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Public title
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Effect of combined zinc and magnesium 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
Individuals aged 18 to 40 years.
Exclusion criteria:
Androgen-secreting tumors
cardiovascular diseases and diabetes
Pregnant women
Thyroid dysfunction
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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, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly 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 Naghavi 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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2018-07-30, 1397/05/08
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1397.026
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 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
2
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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
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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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
3
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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 Triglycerides
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Method of measurement
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Enzymatic kit
4
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Description
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Expressed levels of PPAR-γ gene
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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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PCR
5
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Description
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Expressed levels of GLUT-1 gene
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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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PCR
6
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Description
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Expressed levels of LDL-R gene
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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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PCR
Intervention groups
1
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Description
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Intervention group: 250 mg magnesium oxide (21st Century, Arizona, USA) + 220 mg of zinc sulfate (Alhavi Pharmaceutical Company, Tehran, 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, daily, for 12 weeks orally.
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Category
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Placebo
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, 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