The effect of vitamin D administration on prevention of gestational diabetes and improvement of blood glucose in these individuals and evaluation of changes in neonatal outcomes
Design
In this randomized clinical trial study, 100 patients were randomly divided into two groups using random allocation software, the first group will receive 1000 units of vitamin D daily and the second group will receive 3000 units of vitamin D daily. Serum vitamin D3 levels are monitored at baseline, once a week for 24-28 weeks, along with glucose tolerance testing and once for 35-37 weeks, and all patients will be followed up until delivery. Both groups will be monitored for neonatal outcomes, including NICU admission, birth weight, and type of delivery.
Settings and conduct
This study will be performed on patients referring to Imam Hossein Hospital in Tehran on a single-blind basis. Blindness is such that patients are unaware of the type of vitamin D medication and only the physician will be aware of the therapeutic dose.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All mothers in the first trimester
Having a risk factor for gestational diabetes (including a previous history of gestational diabetes, high body mass index, diabetes type 2 in the first degree family and a history of macrosomal infant birth)
Having informed consent in a pregnant mother
Exclusion criteria:
Impaired glucose of mothers in the first trimester
Evidence of overt diabetes
Intervention groups
Group 1: daily intake of 1000 units of vitamin D
Group 2: Daily intake of 3000 units of vitamin D
Main outcome variables
Vitamin D3 levels at baseline and 24-28 weeks of gestation; Testing for glucose tolerance at baseline and 24-28 weeks and one time at 35-37 weeks of gestation; Neonatal outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N34
Registration date:2019-08-28, 1398/06/06
Registration timing:registered_while_recruiting
Last update:2019-08-28, 1398/06/06
Update count:0
Registration date
2019-08-28, 1398/06/06
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of vitamin D administration in preventing and controlling gestational diabetes and neonatal outcomes
Public title
The effect of vitamin D on the treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All mothers in the first trimester
Having a risk factor for gestational diabetes (including a previous history of gestational diabetes, high body mass index, diabetes type 2 in the first degree family and a history of macrosomal infant birth)
Having informed consent in a pregnant mother
Exclusion criteria:
Impaired glucose of mothers in the first trimester
Evidence of overt diabetes
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, 100 patients were randomly divided into two groups of 50 each.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences