CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03665974
NCT03665974N/ACompleted

Lower Vitamin D Levels During Second Trimester Are Associated With Developing Gestational Diabetes Mellitus: an Observational Cross-sectional Study

Hacettepe University·observational·Posted Sep 11, 2018·Updated Sep 11, 2018

In Brief

An observational study for Deficiency, Vitamin D and Diabetes, Gestational. Completed, enrolled 80 participants.

Detailed Summary

Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with the onset or first recognition during pregnancy. The prevalence of GDM varies from 1-14% due to its variability worldwide, depending on the ethnicity, race, and the diagnostic criteria being applied by each country. In addition to this, approximately 7% of all pregnancies are affected by GDM, ending up more than 200,000 women with GDM per year. A recent study of literature research indicated that Middle East and North Africa had the highest prevalence (median, 12.9%) while Europe had the lowest prevalence (median, 5.8%) in the world. In Turkey the prevalence of GDM ranges between 4-10%, based on the reports in different studies. As a growing health concern, GDM has been associated with short and long-term detrimental health outcomes for women and their offspring. Maternal adverse effects of GDM are preeclampsia, elevated risk of development of hypertension, type 2 diabetes mellitus (T2DM), urinary tract infection and comorbidities following delivery. Macrosomia, neonatal jaundice, birth trauma, respiratory distress syndrome, hypoglycemia are included in short term consequence for the neonates whereas risk for development of impaired glucose tolerance, T2DM, obesity, vascular disorders are long term adverse effects on infant's health. The known risk factors for GDM include family history of T2DM, maternal overweight and obesity, advanced maternal age, history of GDM, having macrosomic infant previously, prior fetal death, and race/ethnicity. In addition to these risk factors, recent studies have been suggested that maternal vitamin D deficiency may be associated with a higher risk of GDM. Vitamin D deficiency during the pregnancy has been associated with adverse outcomes for the pregnant women, such as gestational diabetes mellitus, urinary tract infection, preeclampsia, caesarean section during labour \[25\]. Furthermore, infants born to mothers with lower vitamin D levels have been found to be associated with elevated risk of small for gestational age, low birth weight in the neonatal period, increased risk for cardiovascular disease, respiratory illnesses, type 2 diabetes mellitus in childhood and adulthood. The aim of this study was to compare the serum 25(OH)D levels of women with and without gestational diabetes mellitus (GDM) and identify the serum 25(OH)D level associated with GDM during pregnancy.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2018
Enrollment StartJan 5, 2013
Primary CompletionAug 5, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.8 years ago