Protocol summary
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Study aim
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The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at 24-28 week gestation will be included. Exclusion criteria: Placenta abruption, preeclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases.
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Intervention groups
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Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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Outcomes: Biomarkers of oxidative stress and inflammation (primary outcomes) and pregnancy outcomes (secondary outcome).
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:
IRCT201507035623N47
Registration date:
2015-07-19, 1394/04/28
Registration timing:
retrospective
Last update:
2019-11-10, 1398/08/19
Update count:
1
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Registration date
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2015-07-19, 1394/04/28
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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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Vice chancellor for research, Arak University of Medical Sciences
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Expected recruitment start date
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2015-06-09, 1394/03/19
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Expected recruitment end date
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2015-07-19, 1394/04/28
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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 combined omega-3 and vitamin E supplementation on 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 week gestation
Exclusion criteria:
Placenta abruption
Preeclampsia
Eclampsia
Hypo- and hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases
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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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At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take combined omega-3 and vitamin E supplementation (n = 30) or placebo (n = 30). 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. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology 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. Supplements and placebos capsules are similar in shape and size.
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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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2015-06-08, 1394/03/18
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Ethics committee reference number
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IR.ARAKMU.REC.1394.37
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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Total antioxidant capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
2
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
3
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Description
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Malondialdehyde
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
4
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Description
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Hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
5
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Description
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Nitric oxide
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
Secondary outcomes
1
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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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Scale
2
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Description
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Newborns' weight
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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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Scale
3
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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
4
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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
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
10
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Description
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Newborns' 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
Intervention groups
1
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Description
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Intervention group: Combined omega-3 and vitamin E pearl, 1000 mg omega-3 and 400 IU vitamin E, 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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No
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Title of funding source
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Vice chancellor for research, 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