Status:
RECRUITING
Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy
Lead Sponsor:
Huazhong University of Science and Technology
Conditions:
Glucose Intolerance During Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The goal of this randomized, double-blind, placebo-controlled study included pregnant women at high risk of GDM at 6-15 weeks of gestation is to investigate whether supplementation with vitamin D (160...
Detailed Description
The goal of this randomized, double-blind, placebo-controlled study included pregnant women at high risk of GDM at 6-15 weeks of gestation is to investigate whether supplementation with vitamin D (160...
Eligibility Criteria
Inclusion
- 6-15 weeks of gestation.
- Age 18-45 years old.
- Permanent resident or resident locally at least one year.
- GDM high-risk pregnant women (meeting any of the following criteria):
- Pre-pregnancy body mass index (BMI) ≥24.0 kg/m2,
- History of GDM or a family history of diabetes,
- History of delivery of macrosomia (birth weight \>4000 g),
- HbA1c 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol/L.
Exclusion
- Multiple pregnancy.
- Have received infertility treatment such as in vitro fertilization or intrauterine insemination.
- History of diabetes or current diagnosis of diabetes (including type 1 and type 2 diabetes) or abnormal glucose tolerance at recruitment (fasting blood glucose \>7.0 mmol/L or HbA1c≥6.5%).
- Serious chronic diseases (including cardiovascular and cerebrovascular diseases, cancer, and thyroid dysfunction) or infectious diseases (including hepatitis B, active tuberculosis, acquired immunodeficiency syndrome, and syphilis).
- Severe liver disease (such as cirrhosis) or severe kidney disease (such as renal failure or requiring dialysis).
- Kidney stones, hypercalcemia, hypercalciuria, parathyroid hormone abnormality.
- Any mental disorders, such as schizophrenia, depression, other mental disorders, or bipolar disorder.
- History of allergy or intolerance to vitamin D, chicory root, or starch.
- Have participated in or are participating in other clinical trials within the past 3 months.
- Daily vitamin D intake \>800 IU.
- Inability or refusal to answer and communicate.
- Those who are unwilling to sign the informed consent.
- The researcher thinks that it is not suitable to participate in this research.
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06553729
Start Date
February 24 2025
End Date
December 31 2026
Last Update
September 16 2025
Active Locations (2)
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1
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, China
2
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China