Protocol summary
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Study aim
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The aim of this study is to determine the effects of combined omega-3 fatty acids and vitamin D supplementation on metabolic profiles and pregnancy outcomes in patients with gestational diabetes.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled trial. Random assignment 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: 120 patients with gestational diabetes of eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Taking omega-3 fatty acids supplements, insulin therapy, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism and Smokers
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Intervention groups
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Intervention: Patients will be assigned to receive either combined omega-3 fatty acids or vitamin D (n=30), omega-3 fatty acids (n=30), vitamin D supplements (n=30) and placebo (n=30). Combined omega-3 fatty acids and vitamin D, omega-3 fatty acids, vitamin D supplements and placebos capsules are similar in shape and size.
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Main outcome variables
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Outcomes: Inflammatory factors (primary outcomes), and oxidative stress factors and pregnancy outcomes will be quantified at study baseline and at the end of the trial.
General information
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Reason for update
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Unfortunately, due to carelessness, update request was done after publishing paper. In addition, the requested changes are in accordance with the approved proposal and with the coordination of Vice Chancellor of Research of Ardabil University of Medical Sciences
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201701305623N106
Registration date:
2017-02-09, 1395/11/21
Registration timing:
retrospective
Last update:
2019-11-10, 1398/08/19
Update count:
1
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Registration date
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2017-02-09, 1395/11/21
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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, Ardabil University of Medical Sciences
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Expected recruitment start date
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2016-09-08, 1395/06/18
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Expected recruitment end date
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2016-11-08, 1395/08/18
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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 fatty acids and vitamin D supplementation compared with the placebo on metabolic profiles and pregnancy outcomes in patients with gestational diabetes
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Public title
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Effect of supplementation in treatment of patients with 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:
Patients with gestational diabetes
Age range of 18 to 40 years
Exclusion criteria:
Taking omega-3 fatty acids supplements
Insulin therapy
Placenta abruption
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
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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:
120
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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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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology clinics, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.Participants, investigators or the assessors of the outcomes are unaware of the study groups.The appearance of the placebo capsule is indistinguishable in color, shape, size, and packaging, smell and taste from vitamin D and omega-3 fatty acids capsules.
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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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2016-09-07, 1395/06/17
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Ethics committee reference number
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IR.ARUMS.REC.1395.35
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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E28.2
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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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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
Secondary outcomes
1
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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
2
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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
3
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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
4
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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
5
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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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Girth measuring tape
6
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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
7
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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
8
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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
9
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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
10
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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
Intervention groups
1
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Description
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Intervention group: Combined 2000 mg omega-3 fatty acids daily (Zahravi, Tabriz, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), 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: 2000 mg omega-3 fatty acids daily (Zahravi, Tabriz, Iran), 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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Intervention group: 5000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally.
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Category
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Treatment - Drugs
4
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Description
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Control group: Omega-3 placebo daily (Zahravi, Tabriz, Iran) and vitamin D placebo every 2 weeks (Zahravi, Tabriz, Iran), 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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Vice chancellor for research, Ardabil 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