Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes

NCT05212519 | Unknown DMC

• 1 other identifier: rszqwssdspyrsqtnbjrsjjdxgx
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 provide a basis for the prevention and treatment of GDM.

Conditions

GDM

Outcome Measures

Primary Outcomes (1)

• Whether suffering from gestational diabetes

  Low vitamin D levels are more likely to develop diabetes

  2022-1-1to2024-1-1

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• (1) 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.

Sponsors & Collaborators

• Min Shang: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum 25-(OH)D3

Study Officials

• min shang, MedicalPhD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Obstetrics and Gynecology, Beijing Friendship Hospital

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 28, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)