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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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5 November 2019 |
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Main ID: |
IRCT201406305623N20 |
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Date of registration:
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2014-07-16 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of supplementation in treatment of gestational diabetes
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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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Date of first enrolment:
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2014-05-10 |
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Target sample size:
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54 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/6050 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Zatollah Asemi
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Address:
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Nutrition PhD
81151-87159
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 31 5546 3378 |
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Email:
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irasemi_r@yahoo.com |
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Affiliation:
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Kashan University of Medical Science |
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Name:
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Zatollah Asemi
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Address:
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Ghotbe Ravandi Boulevard, Kashan
81151-87159
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 31 5546 3378 |
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Email:
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asemi_z@kaums.ac.ir |
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Affiliation:
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Kashan University of Medical Sciences |
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Key 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
Age minimum:
18 years
Age maximum:
40 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Gestational diabetes.
Diabetes mellitus in pregnancy, unspecified
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O24.9
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Intervention(s)
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Intervention 1: Intervention group: Omega-3 pearl, 1000 mg, daily, for 6 weeks orally. Intervention 2: Control group: Placebo pearl, daily, for 6 weeks orally.
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Primary Outcome(s)
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Maternal hospitalization. Timepoint: After delivery. Method of measurement: Medical record.
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Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.
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Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.
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Infants' head circumference. Timepoint: Delivery time. Method of measurement: Tape.
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Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.
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Polyhydramnios. Timepoint: After the intervention. Method of measurement: Sonography.
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Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.
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Infants' weight. Timepoint: Delivery time. Method of measurement: Scale.
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Newborns' length. Timepoint: Delivery time. Method of measurement: Tape.
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Secondary Outcome(s)
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Total antioxidant. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.
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Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.
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Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: ELISA kit.
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Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.
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Nitric oxide. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.
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Source(s) of Monetary Support
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Arak University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Arak University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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