Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on gene expression related to insulin and lipid in patients of 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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Among patients with gestational diabetes referred to Kosar gynecology Clinic affiliated to Arak University of Medical Sciences, 90 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with gestational diabetes, aged 18 to 40 years. Exclusion criteria: Taking vitamin D, probiotic and/or symbiotic during the last 3 months prior to the intervention, insulin therapy during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers.
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Intervention groups
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Intervention: Patients will be assigned into three groups to receive combined probiotic and vitamin D (n=30) or probiotic (n=30) or placebo (n=30). Probiotic, vitamin D and placebos capsules are similar in shape and size.
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Main outcome variables
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Outcomes: Insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and 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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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201706075623N119
Registration date:
2017-06-09, 1396/03/19
Registration timing:
registered_while_recruiting
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2017-06-09, 1396/03/19
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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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2017-05-16, 1396/02/26
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Expected recruitment end date
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2017-07-17, 1396/04/26
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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 probiotic and vitamin D supplementation compared with the placebo on metabolic profiles in women with gestational diabetes
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Public title
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Effect of supplementation in treatment of women 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
Aged 18 to 40 years
Exclusion criteria:
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Taking vitamin D, probiotic and/or symbiotic supplements during the last 3 months prior to the intervention
Insulin therapy during the intervention
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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:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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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.
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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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2017-05-15, 1396/02/25
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Ethics committee reference number
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IR.ARAKMU.REC.1396.26
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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Using HOMA formula
Secondary outcomes
1
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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
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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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
4
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Description
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Total antioxidant capacity
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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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Total 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
6
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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
7
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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
8
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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
9
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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
10
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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
11
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Description
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Fasting plasma glucose
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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
12
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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
13
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Description
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Polyhydramnios
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Timepoint
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End-of-trial
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Method of measurement
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Sonographic
14
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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
15
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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
16
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Description
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Newborns' hypoglycemia
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Timepoint
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After delivery
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Method of measurement
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Enzymatic kit
17
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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
18
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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
19
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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
20
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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
21
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Description
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Newborns' length
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Timepoint
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After delivery
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Method of measurement
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Tape
Intervention groups
1
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Description
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Intervention group: Probiotic supplements (Zist Takhmir, Tehran, Iran), 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum, 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: Probiotic and vitamin D placebos capsule (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, 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: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, 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