Protocol summary
-
Study aim
-
Objective: The aim of this study is to determine the effects of combined vitamin E and zinc supplementation on metabolic profiles and gene expression related to insulin and lipid in patients with gestational diabetes mellitus.
-
Design
-
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive combined vitamin E and zinc supplement (n=30) or placebo (n=30).
-
Settings and conduct
-
Among patients with gestational diabetes referred to Naghavi gynecology Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention, insulin therapy required during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism.
-
Intervention groups
-
Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
-
Main outcome variables
-
Outcomes: Markers of glycemic control (primary outcomes) and lipid profile and gene expression related to insulin and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20170513033941N26
Registration date:
2018-01-07, 1396/10/17
Registration timing:
retrospective
Last update:
2019-09-22, 1398/06/31
Update count:
1
-
Registration date
-
2018-01-07, 1396/10/17
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2017-11-27, 1396/09/06
-
Expected recruitment end date
-
2018-01-05, 1396/10/15
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Clinical trial of the effect of combined vitamin E and zinc supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with gestational diabetes mellitus
-
Public title
-
Effect of combined vitamin E and zinc supplementation in treatment of gestational diabetes mellitus
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention
Insulin therapy required during the intervention
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
To decrease potential confounding effects, after balanced blocked randomisation, all participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-11-26, 1396/09/05
-
Ethics committee reference number
-
IR.NIMAD.REC.1396.133
Health conditions studied
1
-
Description of health condition studied
-
Gestational diabetes mellitus
-
ICD-10 code
-
O24.9
-
ICD-10 code description
-
Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Elisa kit
2
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Calculation using HOMA formula
Secondary outcomes
1
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
2
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
3
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
4
-
Description
-
Expressed levels of PPAR-γ gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
5
-
Description
-
LDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
6
-
Description
-
VLDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
7
-
Description
-
Expressed levels of LDLR gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
Intervention groups
1
-
Description
-
Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
National Institute for Medical Research Development of Iran (NIMAD)
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available