Deficiency, Vitamin DNCT03665974
The Relation Between Vitamin D and Gestational Diabetes Mellitus
An observational study of Deficiency, Vitamin D and Diabetes, Gestational, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Deficiency, Vitamin D, Diabetes, Gestational
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2013to 5 Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant between 20-40 years in age, in their 24-28th gestational week applied to Gulhane Education and Research Hospital were recruited. This study must recruit 40 women for each group to have 80% study power with 5% type I error level to detect a clinically significant difference.
Who may be able to join
- Singleton pregnancy,
- Aged in 20-40 years,
- Gestational age 24-28 weeks,
- Non-history of acute or chronic diseases.
Who cannot join
- History of GDM,
- Type 1 and 2 diabetes mellitus,
- Preeclampsia,
- Polycystic ovary syndrome,
- Thyroid disease
- Parathyroid disease,
Show all 11Show fewer
- Metabolic bone disease,
- Kidney disease,
- Abnormal liver function,
- Multiple pregnancy, or
- Women receiving drugs related to calcium and vitamin D metabolism (with the exception of routine vitamin supplements prescribed during pregnancy)
About this study
Official title: Lower Vitamin D Levels During Second Trimester Are Associated With Developing Gestational Diabetes Mellitus: an Observational Cross-sectional Study
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.
Read more
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.
Read the detailed description
In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant between 20-40 years in age, in their 24-28th gestational week applied to Gulhane Education and Research Hospital (Ankara, Turkey) were recruited between January 2014 to March 2014. Inclusion criteria were singleton pregnancy, aged 20-40 years, gestational age 24-28 weeks, non-history of acute or chronic diseases. The exclusion criteria included alcohol using, smoking, history of GDM, diagnosed with type 1 and 2 diabetes mellitus, preeclampsia, polycystic ovary syndrome, thyroid and parathyroid disease, metabolic bone disease, kidney disease, abnormal liver function, multiple pregnancy, or women receiving drugs related to calcium and vitamin D metabolism (with the exception of routine vitamin supplements prescribed during pregnancy). We randomly selected the 40 pregnant women diagnosed GDM by two-step procedure based on Carpenter-Coustan criteria. Women with GDM did not receive any type of the medications such as insulin or medical nutrition therapy. We also randomly selected 40 healthy pregnant women with normal serum glucose levels in the same period. This study must recruit 40 women for each group to have 80% study power with 5% type I error level to detect a clinically significant difference.
The study was approved by the ethic committee of Gulhane Education and Research Hospital, Ankara, Turkey with the number 50687469-1491-2721-13/1648.4-2882. Before commencing the research, not only women got clued in information about the study procedure and objective but also a written informed consent was obtained from all participants.
GDM screening at this hospital involves a two-step procedure. At the outset, 50 g 1 hour glucose challenge test (GCT) was used to screen for GDM at 24th and 28th weeks of gestation. Women with abnormal glucose levels ≥130 mg/dL (7.2 mmol/L) after 1 hour GCT underwent a standard 100 g 3 hour oral glucose tolerance test (OGTT) performed in the morning after eight hours overnight fasting. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL (10.0 mmol/L), 2 hours ≥ 155 mg/dL (8.6 mmol/L), and 3 hours ≥ 140 mg/dL (7.8 mmol/L).
Demographic and individual information such as maternal age, gestational week, parity were recorded. Weight and height of women with light clothes and without shoes were measured via a digital Seca Scale. BMI (Body Mass Index) was calculated by using the following formula: BMI=Weight (kg)/[Height (m) × Height (m)] and evaluated based on classification of (World Health Organisation) WHO as follows: >18.5 kg/m2 defined as underweight, 18.5-24.9 kg/m2 defined as normal weight range, 25.0-29.9 kg/m2 defined as overweight and ≥30.0 kg/m2 defined as obese. Investigators collected blood samples from each women between 24th and 28th weeks of pregnancy during their scheduled antenatal visit to determine the serum 25-hydroxyvitamin D [(25OHD)] concentration.
Levels of 25(OH)D on serum was measured by high performance liquid chromatography (HPLC) in biochemistry laboratory at Gulhane Education and Research Hospital. Investigators used clinical cutoffs based Institute of Medicine (IOM) criteria to categorize 25(OH)D levels: severe deficiency (<10 ng/mL), deficiency (10-20 ng/mL) and insufficiency (20-30 ng/mL).
Firstly, the variables were tested using Kolmogorov-Smirnov test to determine whether they are normally distributed. Descriptive analyses were presented as mean±standard deviation (SD) for normally distributed variables. Since the maternal age, serum 25(OH)D, log-transformed 50 g 1 hour GCT and log-transformed fasting blood glucose values were normally distributed; the Student's t-test was used to compare these parameters between women with and without GDM. Descriptive analyses were presented as median(min-max) for the non-normally distributed. Since the gestational age, gravity, and parity were not normally distributed; Mann-Whitney U test was used to compare these parameters between groups. Chi square test was used for categorical variable to compare the proportions in different groups. As both parameters were normally distributed, the correlation coefficients and their significance were calculated using the Pearson test. For the multivariate analysis, the possible factors identified with univariate analyses were further entered into the logistic regression analysis to determine independent predictors of women outcome. Hosmer-Lemeshow goodness of fit statistics were used to assess model fit. A 5% type-I error level was used to infer statistical significance. Receiver operating characteristics (ROC) analysis was done to identify the optimal cutoff point values of maternal serum 25OHD levels. All the data collected from the participants were analyzed using Statistical Package for the Social Sciences (SPSS) version 22.0 (SPSS Inc., Chicago, Illinois, USA) and p<0.05 was considered statistically significant.
- Conditions
- Deficiency, Vitamin D, Diabetes, Gestational
- Keywords
- Pregnancy, deficinecy, vitamin D, diabetes, gestational
- Medical subject headings
- Vitamin D Deficiency, Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with gestational diabetes mellitus | GDM screening at this hospital involves a two-step procedure. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed based on Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL ( 10.0 mmol/L), 2 hour ≥ 155 mg/dL (8.6 mmol/L), and 3 hour ≥ 140 mg/dL (7.8 mmol/L). | |
| Women non gestational diabetes mellitus | Women with normal serum glucose levels ≤129 mg/dL (7.2 mmol/L) after GCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D levels
Levels of 25(OH)D on serum was measured by high performance liquid chromatography (HPLC) in biochemistry laboratory at Gulhane Education and Research Hospital.
Measured: 24-28. weeks of pregnancy
Pre-pregnancy BMI
BMI (Body Mass Index) was calculated by using the following formula:
BMI=Weight (kg)/[Height (m) × Height (m)].
Measured: 24-28. weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start5 Jan 2013
- Primary completion5 Aug 2013
- Study completion5 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Deficiency, Vitamin DStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F. Gülhan Samur, Hacettepe University
- Investigators
- Gülhan SAMUR, Professor, Principal investigator, Hacettepe UniversityGözde EDE, MSci, Study chair, Hacettepe UniversityMüfit YENEN, Professor, Study chair, Saglik Bilimleri UniversitesiUğur KESKİN, Assoc. Prof., Study chair, Gulhane Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665974
- Sponsor's protocol ID
- Hacettepe University Nutrition
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kennelly MA, McAuliffe FM. Prediction and prevention of Gestational Diabetes: an update of recent literature. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:92-8. doi: 10.1016/j.ejogrb.2016.03.032. Epub 2016 Apr 4.
PubMed 27235645Damm P, Houshmand-Oeregaard A, Kelstrup L, Lauenborg J, Mathiesen ER, Clausen TD. Gestational diabetes mellitus and long-term consequences for mother and offspring: a view from Denmark. Diabetologia. 2016 Jul;59(7):1396-1399. doi: 10.1007/s00125-016-3985-5. Epub 2016 May 12.
PubMed 27174368Zhang MX, Pan GT, Guo JF, Li BY, Qin LQ, Zhang ZL. Vitamin D Deficiency Increases the Risk of Gestational Diabetes Mellitus: A Meta-Analysis of Observational Studies. Nutrients. 2015 Oct 1;7(10):8366-75. doi: 10.3390/nu7105398.
PubMed 26437429Poel YH, Hummel P, Lips P, Stam F, van der Ploeg T, Simsek S. Vitamin D and gestational diabetes: a systematic review and meta-analysis. Eur J Intern Med. 2012 Jul;23(5):465-9. doi: 10.1016/j.ejim.2012.01.007. Epub 2012 Feb 21.
PubMed 22726378Burris HH, Rifas-Shiman SL, Kleinman K, Litonjua AA, Huh SY, Rich-Edwards JW, Camargo CA Jr, Gillman MW. Vitamin D deficiency in pregnancy and gestational diabetes mellitus. Am J Obstet Gynecol. 2012 Sep;207(3):182.e1-8. doi: 10.1016/j.ajog.2012.05.022. Epub 2012 Jun 1.
PubMed 22717271Mutlu N, Esra H, Begum A, Fatma D, Arzu Y, Yalcin H, Fatih K, Selahattin K. Relation of maternal vitamin D status with gestational diabetes mellitus and perinatal outcome. Afr Health Sci. 2015 Jun;15(2):523-31. doi: 10.4314/ahs.v15i2.27.
PubMed 26124799American Diabetes Association. Gestational diabetes mellitus. Diabetes Care. 2004 Jan;27 Suppl 1:S88-90. doi: 10.2337/diacare.27.2007.s88. No abstract available.
PubMed 14693936Wei SQ. Vitamin D and pregnancy outcomes. Curr Opin Obstet Gynecol. 2014 Dec;26(6):438-47. doi: 10.1097/GCO.0000000000000117.
PubMed 25310531Durnwald C. Gestational diabetes: Linking epidemiology, excessive gestational weight gain, adverse pregnancy outcomes, and future metabolic syndrome. Semin Perinatol. 2015 Jun;39(4):254-8. doi: 10.1053/j.semperi.2015.05.002. Epub 2015 Jun 17.
PubMed 26093518Sreelakshmi PR, Nair S, Soman B, Alex R, Vijayakumar K, Kutty VR. Maternal and neonatal outcomes of gestational diabetes: A retrospective cohort study from Southern India. J Family Med Prim Care. 2015 Jul-Sep;4(3):395-8. doi: 10.4103/2249-4863.161331.
PubMed 26288780Domaracki P, Sadlecki P, Odrowaz-Sypniewska G, Dzikowska E, Walentowicz P, Siodmiak J, Grabiec M, Walentowicz-Sadlecka M. Serum 25(OH) Vitamin D Levels in Polish Women during Pregnancies Complicated by Hypertensive Disorders and Gestational Diabetes. Int J Mol Sci. 2016 Sep 27;17(10):1574. doi: 10.3390/ijms17101574.
PubMed 27690002Lu M, Xu Y, Lv L, Zhang M. Association between vitamin D status and the risk of gestational diabetes mellitus: a meta-analysis. Arch Gynecol Obstet. 2016 May;293(5):959-66. doi: 10.1007/s00404-016-4010-4. Epub 2016 Jan 29.
PubMed 26825733Pirjani R, Shirzad N, Qorbani M, Phelpheli M, Nasli-Esfahani E, Bandarian F, Hemmatabadi M. Gestational diabetes mellitus its association with obesity: a prospective cohort study. Eat Weight Disord. 2017 Sep;22(3):445-450. doi: 10.1007/s40519-016-0332-2. Epub 2016 Oct 17.
PubMed 27747467Jelsma JG, van Poppel MN, Galjaard S, Desoye G, Corcoy R, Devlieger R, van Assche A, Timmerman D, Jans G, Harreiter J, Kautzky-Willer A, Damm P, Mathiesen ER, Jensen DM, Andersen L, Dunne F, Lapolla A, Di Cianni G, Bertolotto A, Wender-Oegowska E, Zawiejska A, Blumska K, Hill D, Rebollo P, Snoek FJ, Simmons D. DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol. BMC Pregnancy Childbirth. 2013 Jul 5;13:142. doi: 10.1186/1471-2393-13-142.
PubMed 23829946
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Vitamin D Levels During Second Trimester Are Associated With Developing Gestational Diabetes Mellitus: an Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03665974
- Acronym / sponsor ID
- Hacettepe University Nutrition
- Conditions
- Deficiency, Vitamin D, Diabetes, Gestational
- Keywords
- Pregnancy, deficinecy, vitamin D, diabetes, gestational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2013 (actual)
- Primary completion
- 5 Aug 2013 (actual)
- Study completion
- 5 Aug 2013 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant between 20-40 years in age, in their 24-28th gestational week applied to Gulhane Education and Research Hospital (Ankara, Turkey) were recruited between January 2014 to March 2014. Inclusion criteria were singleton pregnancy, aged 20-40 years, gestational age 24-28 weeks, non-history of acute or chronic diseases. The exclusion criteria included alcohol using, smoking, history of GDM, diagnosed with type 1 and 2 diabetes mellitus, preeclampsia, polycystic ovary syndrome, thyroid and parathyroid disease, metabolic bone disease, kidney disease, abnormal liver function, multiple pregnancy, or women receiving drugs related to calcium and vitamin D metabolism (with the exception of routine vitamin supplements prescribed during pregnancy). We randomly selected the 40 pregnant women diagnosed GDM by two-step procedure based on Carpenter-Coustan criteria. Women with GDM did not receive any type of the medications such as insulin or medical nutrition therapy. We also randomly selected 40 healthy pregnant women with normal serum glucose levels in the same period. This study must recruit 40 women for each group to have 80% study power with 5% type I error level to detect a clinically significant difference.
The study was approved by the ethic committee of Gulhane Education and Research Hospital, Ankara, Turkey with the number 50687469-1491-2721-13/1648.4-2882. Before commencing the research, not only women got clued in information about the study procedure and objective but also a written informed consent was obtained from all participants.
GDM screening at this hospital involves a two-step procedure. At the outset, 50 g 1 hour glucose challenge test (GCT) was used to screen for GDM at 24th and 28th weeks of gestation. Women with abnormal glucose levels ≥130 mg/dL (7.2 mmol/L) after 1 hour GCT underwent a standard 100 g 3 hour oral glucose tolerance test (OGTT) performed in the morning after eight hours overnight fasting. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL (10.0 mmol/L), 2 hours ≥ 155 mg/dL (8.6 mmol/L), and 3 hours ≥ 140 mg/dL (7.8 mmol/L).
Demographic and individual information such as maternal age, gestational week, parity were recorded. Weight and height of women with light clothes and without shoes were measured via a digital Seca Scale. BMI (Body Mass Index) was calculated by using the following formula: BMI=Weight (kg)/[Height (m) × Height (m)] and evaluated based on classification of (World Health Organisation) WHO as follows: >18.5 kg/m2 defined as underweight, 18.5-24.9 kg/m2 defined as normal weight range, 25.0-29.9 kg/m2 defined as overweight and ≥30.0 kg/m2 defined as obese. Investigators collected blood samples from each women between 24th and 28th weeks of pregnancy during their scheduled antenatal visit to determine the serum 25-hydroxyvitamin D [(25OHD)] concentration.
Levels of 25(OH)D on serum was measured by high performance liquid chromatography (HPLC) in biochemistry laboratory at Gulhane Education and Research Hospital. Investigators used clinical cutoffs based Institute of Medicine (IOM) criteria to categorize 25(OH)D levels: severe deficiency (<10 ng/mL), deficiency (10-20 ng/mL) and insufficiency (20-30 ng/mL).
Firstly, the variables were tested using Kolmogorov-Smirnov test to determine whether they are normally distributed. Descriptive analyses were presented as mean±standard deviation (SD) for normally distributed variables. Since the maternal age, serum 25(OH)D, log-transformed 50 g 1 hour GCT and log-transformed fasting blood glucose values were normally distributed; the Student's t-test was used to compare these parameters between women with and without GDM. Descriptive analyses were presented as median(min-max) for the non-normally distributed. Since the gestational age, gravity, and parity were not normally distributed; Mann-Whitney U test was used to compare these parameters between groups. Chi square test was used for categorical variable to compare the proportions in different groups. As both parameters were normally distributed, the correlation coefficients and their significance were calculated using the Pearson test. For the multivariate analysis, the possible factors identified with univariate analyses were further entered into the logistic regression analysis to determine independent predictors of women outcome. Hosmer-Lemeshow goodness of fit statistics were used to assess model fit. A 5% type-I error level was used to infer statistical significance. Receiver operating characteristics (ROC) analysis was done to identify the optimal cutoff point values of maternal serum 25OHD levels. All the data collected from the participants were analyzed using Statistical Package for the Social Sciences (SPSS) version 22.0 (SPSS Inc., Chicago, Illinois, USA) and p<0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with gestational diabetes mellitus | – | –GDM screening at this hospital involves a two-step procedure. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed based on Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL ( 10.0 mmol/L), 2 hour ≥ 155 mg/dL (8.6 mmol/L), and 3 hour ≥ 140 mg/dL (7.8 mmol/L). |
| Women non gestational diabetes mellitus | – | –Women with normal serum glucose levels ≤129 mg/dL (7.2 mmol/L) after GCT. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant between 20-40 years in age, in their 24-28th gestational week applied to Gulhane Education and Research Hospital were recruited. This study must recruit 40 women for each group to have 80% study power with 5% type I error level to detect a clinically significant difference.
Key inclusion criteria (4 listed)
- Singleton pregnancy,
- Aged in 20-40 years,
- Gestational age 24-28 weeks,
- Non-history of acute or chronic diseases.
Key exclusion criteria (11 listed)
- History of GDM,
- Type 1 and 2 diabetes mellitus,
- Preeclampsia,
- Polycystic ovary syndrome,
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum 25(OH)D levels
Time frame: 24-28. weeks of pregnancy
Levels of 25(OH)D on serum was measured by high performance liquid chromatography (HPLC) in biochemistry laboratory at Gulhane Education and Research Hospital.
Pre-pregnancy BMI
Time frame: 24-28. weeks of pregnancy
BMI (Body Mass Index) was calculated by using the following formula: BMI=Weight (kg)/[Height (m) × Height (m)].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Background: PubMed 27235645Kennelly MA, McAuliffe FM. Prediction and prevention of Gestational Diabetes: an update of recent literature. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:92-8. doi: 10.1016/j.ejogrb.2016.03.032. Epub 2016 Apr 4.
- Background: PubMed 27174368Damm P, Houshmand-Oeregaard A, Kelstrup L, Lauenborg J, Mathiesen ER, Clausen TD. Gestational diabetes mellitus and long-term consequences for mother and offspring: a view from Denmark. Diabetologia. 2016 Jul;59(7):1396-1399. doi: 10.1007/s00125-016-3985-5. Epub 2016 May 12.
- Background: PubMed 26437429Zhang MX, Pan GT, Guo JF, Li BY, Qin LQ, Zhang ZL. Vitamin D Deficiency Increases the Risk of Gestational Diabetes Mellitus: A Meta-Analysis of Observational Studies. Nutrients. 2015 Oct 1;7(10):8366-75. doi: 10.3390/nu7105398.
- Background: PubMed 22726378Poel YH, Hummel P, Lips P, Stam F, van der Ploeg T, Simsek S. Vitamin D and gestational diabetes: a systematic review and meta-analysis. Eur J Intern Med. 2012 Jul;23(5):465-9. doi: 10.1016/j.ejim.2012.01.007. Epub 2012 Feb 21.
- Background: PubMed 22717271Burris HH, Rifas-Shiman SL, Kleinman K, Litonjua AA, Huh SY, Rich-Edwards JW, Camargo CA Jr, Gillman MW. Vitamin D deficiency in pregnancy and gestational diabetes mellitus. Am J Obstet Gynecol. 2012 Sep;207(3):182.e1-8. doi: 10.1016/j.ajog.2012.05.022. Epub 2012 Jun 1.
- Background: PubMed 26124799Mutlu N, Esra H, Begum A, Fatma D, Arzu Y, Yalcin H, Fatih K, Selahattin K. Relation of maternal vitamin D status with gestational diabetes mellitus and perinatal outcome. Afr Health Sci. 2015 Jun;15(2):523-31. doi: 10.4314/ahs.v15i2.27.
- Results publication: PubMed 14693936American Diabetes Association. Gestational diabetes mellitus. Diabetes Care. 2004 Jan;27 Suppl 1:S88-90. doi: 10.2337/diacare.27.2007.s88. No abstract available.
- Results publication: PubMed 25310531Wei SQ. Vitamin D and pregnancy outcomes. Curr Opin Obstet Gynecol. 2014 Dec;26(6):438-47. doi: 10.1097/GCO.0000000000000117.
- Results publication: PubMed 26093518Durnwald C. Gestational diabetes: Linking epidemiology, excessive gestational weight gain, adverse pregnancy outcomes, and future metabolic syndrome. Semin Perinatol. 2015 Jun;39(4):254-8. doi: 10.1053/j.semperi.2015.05.002. Epub 2015 Jun 17.
- Results publication: PubMed 26288780Sreelakshmi PR, Nair S, Soman B, Alex R, Vijayakumar K, Kutty VR. Maternal and neonatal outcomes of gestational diabetes: A retrospective cohort study from Southern India. J Family Med Prim Care. 2015 Jul-Sep;4(3):395-8. doi: 10.4103/2249-4863.161331.
- Results publication: PubMed 27690002Domaracki P, Sadlecki P, Odrowaz-Sypniewska G, Dzikowska E, Walentowicz P, Siodmiak J, Grabiec M, Walentowicz-Sadlecka M. Serum 25(OH) Vitamin D Levels in Polish Women during Pregnancies Complicated by Hypertensive Disorders and Gestational Diabetes. Int J Mol Sci. 2016 Sep 27;17(10):1574. doi: 10.3390/ijms17101574.
- Results publication: PubMed 26825733Lu M, Xu Y, Lv L, Zhang M. Association between vitamin D status and the risk of gestational diabetes mellitus: a meta-analysis. Arch Gynecol Obstet. 2016 May;293(5):959-66. doi: 10.1007/s00404-016-4010-4. Epub 2016 Jan 29.
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Vision Loss Night, Vision Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülhan SAMUR, Professor principal investigator
Hacettepe University
Gözde EDE, MSci study chair
Hacettepe University
Müfit YENEN, Professor study chair
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
An observational study of Deficiency, Vitamin D and Diabetes, Gestational, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D levels (time frame: 24-28. weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665974, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.