Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of magnesium supplementation on gene expression related to inflammation and pregnancy outcomes in patients with gestational diabetes mellitus.
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Design
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Study design: 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 magnesium supplement (n=20) or placebo (n=20).
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Settings and conduct
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Among patients with gestational diabetes referred to Akbarabadi Clinic affiliated to Iran 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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Taking magnesium and antioxidants supplements 3 months before the intervention, needing insulin therapy, pre-eclampsia, eclampsia, hypo and hyperthyroidism, and smokers.
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Intervention groups
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Intervention group: 250 mg magnesium (21st Century Pharmaceutical Company, Arizona, USA), daily for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
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Main outcome variables
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Outcomes: Gene expression related to inflammation (primary outcome) and pregnancy outcomes (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:
IRCT20170513033941N25
Registration date:
2017-12-29, 1396/10/08
Registration timing:
retrospective
Last update:
2019-09-13, 1398/06/22
Update count:
1
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Registration date
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2017-12-29, 1396/10/08
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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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2017-11-16, 1396/08/25
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Expected recruitment end date
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2017-11-30, 1396/09/09
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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 magnesium supplementation compared with the placebo on gene expression related to inflammation and pregnancy outcomes in women with gestational diabetes mellitus
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Public title
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Effect of magnesium supplementation in treatment of gestational diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Taking magnesium and antioxidants supplements 3 months before the intervention
Needing insulin therapy
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
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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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2
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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 and after balanced randomisation, subjects will be allocated into two groups to receive supplement 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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Ethics committees
1
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Ethics committee
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Approval date
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2017-11-15, 1396/08/24
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Ethics committee reference number
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IR.IUMS.FMD.REC.1396.9411290018
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes mellitus
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ICD-10 code
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O24.9
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ICD-10 code description
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Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
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Description
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Expressed levels of TNF-a gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Expressed levels of IL-1 gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
3
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Description
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Expressed levels of IL-8 gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
Secondary outcomes
1
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Description
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Expressed levels of TGF-B gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Expressed levels of VEGF gene
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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PCR
3
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Description
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Newborn's head circumference
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Timepoint
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Delivery time
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Method of measurement
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Tape
4
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Description
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Newborn's weight
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Timepoint
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Delivery time
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Method of measurement
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Scale
5
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Description
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Polyhydramnios
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Timepoint
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End-of-trial
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Method of measurement
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Sonography
6
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Description
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Newborn length
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Timepoint
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The first 24 h after birth
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Method of measurement
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Girth measuring tape
Intervention groups
1
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Description
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Intervention group: 250 mg magnesium (21st Century Pharmaceutical Company, Arizona, USA), daily for 6 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), daily for 6 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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Iran 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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available