Clinical trial of the effect of zinc supplementation compared with the placebo on expressed levels of PPAR-γ and GLUT1 genes in newborns of women with gestational diabetes
Objective: The aim of this study is to determine the effects of zinc supplementation on expressed levels of PPAR-γ and GLUT1 genes in newborns of women with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with gestational diabetes referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 40 patients will be selected according to inclusion and eclusion criteria. Intervention: Patients will be assigned into two groups to receive zinc supplements (n=20) or placebo (n=20). Zinc supplements and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Although, the duration of intervention was 6 weeks, all women were followed up until the delivery. Outcomes: Blood samples from cord will be taken to quantify expressed levels of PPAR-γ and GLUT1 genes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604195623N76
Registration date:2016-05-01, 1395/02/12
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-05-01, 1395/02/12
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of zinc supplementation compared with the placebo on expressed levels of PPAR-γ and GLUT1 genes in newborns of women with gestational diabetes
Public title
Effect of supplementation in treatment of women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with gestational diabetes; aged 18 to 40 years.
Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences