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 vitamin D and evening primrose oil supplementation on metabolic profiles 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 Gynecology 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 weeks 24-28 of gestation will be included. Exclusion criteria: Pre-eclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases and those requiring commencement of insulin therapy during treatment.
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Intervention groups
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Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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Outcomes: Markers of insulin resistance (primary outcomes) and lipid profiles (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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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201509115623N52
Registration date:
2015-09-16, 1394/06/25
Registration timing:
registered_while_recruiting
Last update:
2019-09-22, 1398/06/31
Update count:
1
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Registration date
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2015-09-16, 1394/06/25
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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 Sciences
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Expected recruitment start date
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2015-09-02, 1394/06/11
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Expected recruitment end date
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2015-09-18, 1394/06/27
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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 vitamin D and evening primrose oil supplementation on metabolic profiles 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 weeks 24-28 of gestation
Exclusion criteria:
Pre-eclampsia
Eclampsia
hypo- and hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases
Those requiring commencement of insulin therapy during treatment.
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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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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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2015-09-01, 1394/06/10
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Ethics committee reference number
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IR.ARAKMU.REC.1394.161
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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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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Questionnaire
Secondary outcomes
1
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Description
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Fasting blood sugar
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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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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
4
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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
5
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Description
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VLDL
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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
6
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Description
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LDL
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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: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, 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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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