Protocol summary
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Study aim
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The aim of this study is to determine the effects of omega-3 supplementation on insulin resistance and lipid profiles in gestational diabetes.
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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.
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Settings and conduct
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Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences and Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 56 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 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study.
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Intervention groups
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Intervention: Patients will be assigned to receive omega-3 supplement (n=28) and placebo (n=28).
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Main outcome variables
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Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles (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:
IRCT201312265623N16
Registration date:
2014-03-10, 1392/12/19
Registration timing:
registered_while_recruiting
Last update:
2019-08-11, 1398/05/20
Update count:
1
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Registration date
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2014-03-10, 1392/12/19
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2014-03-03, 1392/12/12
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Expected recruitment end date
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2014-03-15, 1392/12/24
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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 effect of omega-3 supplementation on insulin resistance and lipid profiles in women with gestational diabetes
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Public title
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The effect of omega-3 in the 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:
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
The use of substitute treatments including hormone or vitamin supplements
Patients with pre-eclampsia
Complete bed rest (CBR)
Intra uterine fetal death (IUFD)
Placenta abruption
Preterm delivery
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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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N/A
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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:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomly allocated into two groups to take either 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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Ethics committees
1
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Ethics committee
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Approval date
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2014-03-03, 1392/12/12
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Ethics committee reference number
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29/5/1/5007/P
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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Diabetes mellitus in pregnancy, unspecified
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 6 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 6 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 6 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 6 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 6 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: Magnesium tablet, 250 mg, 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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Intervention group: Omega-3 pearl, daily for 6 weeks orally.
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo tablet for magnesium, daily for 6 weeks orally.
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Category
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Placebo
4
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Description
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Control group: Placebo pearl for omega-3, 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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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