GDMNCT05212519
Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes
An observational study of GDM, run by Min Shang at 1 site in China.
Trial summary
Explore the specific correlation between different concentration levels of vitamin D in early pregnancy and blood glucose levels at each time node of OGTT, the correlation between different concentrations of vitamin D levels and A1 and A2 diabetes in pregnancy, and the impact on maternal and infant outcomes , And… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2024
- How long will I take part?
- 2 Years
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women aged 18 to 45 years who have received regular antenatal examinations and delivered in the department of obstetrics in Beijing Friendship Hospital, Capital Medical University.
Who may be able to join
- Pregnant women aged 18 to 45 years who have received regular antenatal examinations and delivered in the department of obstetrics in Beijing Friendship Hospital, Capital Medical University.
Who cannot join
- chronic or acute disease history (diabetes mellitus, hypertension,or thyroid disease); (2) any mental disorder; (3) abortion (fetal loss before 28 gestational weeks); (4)multiple fetuses; (5) planning to give birth in other hospitals.
Trial locations and contacts
1 site in 1 country.
About this study
Explore the specific correlation between different concentration levels of vitamin D in early pregnancy and blood glucose levels at each time node of OGTT, the correlation between different concentrations of vitamin D levels and A1 and A2 diabetes in pregnancy, and the impact on maternal and infant outcomes , And provide a basis for the prevention and treatment of GDM.
Read the detailed description
- According to the diagnostic criteria of GDM proposed by the International Association for the Study of Diabetes and Pregnancy (IADPSG), the 18-45-year-old pregnant women who were filed and delivered by the Obstetrics Department of Beijing Friendship Hospital from September 2022 to September 2024 were selected to collect their early pregnancy (pregnancy 1- 3 months) Vitamin d level, divided into three groups: A (<20 ng/ml), B (20~<30 ng/ml), and C (≥30 ng/ml), compare the early pregnancy (1-3 months of pregnancy) Differences in vitamin D levels.
- Follow-up patients with gestational diabetes mellitus are divided into type A1 gestational diabetes patients (GDM 1 group) and type A2 gestational diabetes patients (GDM 2 group) according to whether participant are treated with insulin, and study vitamins through multiple linear and logistic regression models The relationship between D level and GDM and follow-up pregnancy outcome
- Analyze the relationship between the level of vitamin D in early pregnancy and pregnancy complications, such as whether it is combined with premature rupture of membranes, hypertension during pregnancy, whether it is a cesarean section, whether it is a giant baby, whether there is asphyxia in newborns, etc.
- Conditions
- GDM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
For observational research
| Study group | Role | What they receive |
|---|---|---|
| 25-hydroxyvitamin D3≥30 ng/ml | the patients were categorized as having vitamin D sufficiency if its concentrationis ≥30 ng/m | |
| 25-hydroxyvitamin D3< 30 ng/ml | insufficiency if levels are <30 but ≥20 ng/ml, deficiency when levels are <20 but ≥10 ng/ml and severe deficiency with levels <10 ng/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether suffering from gestational diabetes
Low vitamin D levels are more likely to develop diabetes
Measured: 2022-1-1to2024-1-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Min Shang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Shang, Beijing Friendship Hospital
- Investigators
- min shang, MedicalPhD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212519
- Sponsor's protocol ID
- rszqwssdspyrsqtnbjrsjjdxgx
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT05212519
- Acronym / sponsor ID
- rszqwssdspyrsqtnbjrsjjdxgx
- Conditions
- GDM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Min ShangUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 28 Jan 2022 (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.
Explore the specific correlation between different concentration levels of vitamin D in early pregnancy and blood glucose levels at each time node of OGTT, the correlation between different concentrations of vitamin D levels and A1 and A2 diabetes in pregnancy, and the impact on maternal and infant outcomes , And provide a basis for the prevention and treatment of GDM.
Detailed description
- According to the diagnostic criteria of GDM proposed by the International Association for the Study of Diabetes and Pregnancy (IADPSG), the 18-45-year-old pregnant women who were filed and delivered by the Obstetrics Department of Beijing Friendship Hospital from September 2022 to September 2024 were selected to collect their early pregnancy (pregnancy 1- 3 months) Vitamin d level, divided into three groups: A (<20 ng/ml), B (20~<30 ng/ml), and C (≥30 ng/ml), compare the early pregnancy (1-3 months of pregnancy) Differences in vitamin D levels.
- Follow-up patients with gestational diabetes mellitus are divided into type A1 gestational diabetes patients (GDM 1 group) and type A2 gestational diabetes patients (GDM 2 group) according to whether participant are treated with insulin, and study vitamins through multiple linear and logistic regression models The relationship between D level and GDM and follow-up pregnancy outcome
- Analyze the relationship between the level of vitamin D in early pregnancy and pregnancy complications, such as whether it is combined with premature rupture of membranes, hypertension during pregnancy, whether it is a cesarean section, whether it is a giant baby, whether there is asphyxia in newborns, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25-hydroxyvitamin D3≥30 ng/ml | – | –the patients were categorized as having vitamin D sufficiency if its concentrationis ≥30 ng/m |
| 25-hydroxyvitamin D3< 30 ng/ml | – | –insufficiency if levels are <30 but ≥20 ng/ml, deficiency when levels are <20 but ≥10 ng/ml and severe deficiency with levels <10 ng/ml |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 18 to 45 years who have received regular antenatal examinations and delivered in the department of obstetrics in Beijing Friendship Hospital, Capital Medical University.
Key inclusion criteria (1 listed)
- Pregnant women aged 18 to 45 years who have received regular antenatal examinations and delivered in the department of obstetrics in Beijing Friendship Hospital, Capital Medical University.
Key exclusion criteria (1 listed)
- chronic or acute disease history (diabetes mellitus, hypertension,or thyroid disease); (2) any mental disorder; (3) abortion (fetal loss before 28 gestational weeks); (4)multiple fetuses; (5) planning to give birth in other hospitals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| For observational research | Other | 25-hydroxyvitamin D3< 30 ng/ml |
Primary outcome
Whether suffering from gestational diabetes
Time frame: 2022-1-1to2024-1-1
Low vitamin D levels are more likely to develop diabetes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No. no plan
Related trials for GDM
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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.
min shang, MedicalPhD principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GDM, run by Min Shang at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Whether suffering from gestational diabetes (time frame: 2022-1-1to2024-1-1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2022.