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
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.
Design
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=30) or placebo (n=30).
Settings and conduct
Among patients with gestational diabetes referred to Akbarabadi Clinic affiliated to Iran 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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate, taking magnesium supplements before the intervention, needing insulin therapy, placenta abruption,
pre-eclampsia, eclampsia, hypo and hyperthyroidism, and smokers.
Intervention groups
Intervention group: 250 mg magnesium (Jalinous pharmaceutical Company, Tehran, Iran), daily for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N25
Registration date:2017-12-29, 1396/10/08
Registration timing:retrospective
Last update:2017-12-29, 1396/10/08
Update count:1
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-16, 1396/08/25
Expected recruitment end date
2017-11-30, 1396/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of magnesium supplementation in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Unwillingness to cooperate.
Taking magnesium supplements before the intervention
Needing insulin therapy
Placenta abruption
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y), subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-15, 1396/08/24
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411290018
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 6 weeks of intervention