Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes.
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Design
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Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 54 patients will be selected according to inclusion and exclusion criteria.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation. Exclusion Criteria: Pre-existing diabetes, required complex diets, chronic medical conditions, significant psychiatric disease, smokers, kidney or liver diseases, chronic hypertension, hypothyroidism.
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Intervention groups
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Intervention group: Omega-3 pearl, 1000 mg, daily, for 6 weeks orally.
Control group: Placebo pearl, daily, for 6 weeks orally.
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Main outcome variables
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Outcomes: Pregnancy outcomes (primary outcomes),hs-CRP, total nitrite and biomarkers of 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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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201406305623N20
Registration date:
2014-07-16, 1393/04/25
Registration timing:
retrospective
Last update:
2019-10-25, 1398/08/03
Update count:
1
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Registration date
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2014-07-16, 1393/04/25
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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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Arak University of Medical Science
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Expected recruitment start date
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2014-05-10, 1393/02/20
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Expected recruitment end date
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2014-05-28, 1393/03/07
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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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Effect of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes
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Public title
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Effect of 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:
Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
Pre-existing diabetes
Required complex diets
Chronic medical conditions
Significant psychiatric disease
Smokers
Kidney or liver diseases
Chronic hypertension
Hypothyroidism
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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:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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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2014-05-09, 1393/02/19
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Ethics committee reference number
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93-165-20
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes
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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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Infants' weight
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Timepoint
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Delivery time
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Method of measurement
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Scale
2
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Description
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Infants' 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
3
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Description
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Newborns' length
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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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Polyhydramnios
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Timepoint
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After the intervention
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Method of measurement
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Sonography
5
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Description
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Newborn's bilirubin
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Timepoint
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Delivery time
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Method of measurement
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Enzymatic kit
6
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Description
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Apgar score
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Timepoint
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Delivery time
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Method of measurement
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Clinical observation
7
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Description
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Preterm delivery
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Timepoint
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After delivery
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Method of measurement
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Medical record
8
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Description
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Maternal pre-eclampsia
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Timepoint
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After delivery
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Method of measurement
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Medical record
9
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Description
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Maternal hospitalization
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Timepoint
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After delivery
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Method of measurement
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Medical record
Secondary outcomes
1
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Description
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Hs-CRP
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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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Nitric oxide
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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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Spectrophotometry
3
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Description
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Total antioxidant
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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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Spectrophotometry
4
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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 6 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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Glutathione
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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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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: Omega-3 pearl, 1000 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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Control group: Placebo pearl, daily, for 6 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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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