Actively Recruiting
Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy
Led by Huazhong University of Science and Technology · Updated on 2025-09-16
500
Participants Needed
2
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (1600 IU per day) or prebiotics (inulin, 10 gram per day) during pregnancy has beneficial effects on controlling blood glucose during pregnancy.
CONDITIONS
Official Title
Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women between 6 and 15 weeks of gestation
- Age between 18 and 45 years
- Permanent resident or have lived locally for at least one year
- High risk of gestational diabetes mellitus (GDM) defined by any of the following:
- Pre-pregnancy BMI of 24.0 kg/m2 or higher
- History of GDM or a family history of diabetes
- History of delivering a baby weighing more than 4000 grams
- Glycated hemoglobin (HbA1c) between 5.7% and 6.4% or fasting blood glucose between 5.6 and 7.0 mmol/L
- Singleton pregnancy
- No infertility treatment received
You will not qualify if you...
- Multiple pregnancy (twins or more)
- Received infertility treatments such as in vitro fertilization or intrauterine insemination
- History or current diagnosis of diabetes (type 1 or type 2) or abnormal glucose tolerance (fasting blood glucose over 7.0 mmol/L or HbA1c 6.5% or higher)
- Serious chronic diseases (including cardiovascular, cerebrovascular diseases, cancer, thyroid problems) or infectious diseases (including hepatitis B, active tuberculosis, AIDS, syphilis)
- Severe liver disease (e.g., cirrhosis) or severe kidney disease (e.g., renal failure or requiring dialysis)
- Kidney stones, high blood calcium or calcium in urine, parathyroid hormone abnormalities
- Mental health disorders such as schizophrenia, depression, bipolar disorder, or other mental illnesses
- Allergy or intolerance to vitamin D, chicory root, or starch
- Participation in other clinical trials within the past 3 months
- Daily vitamin D intake over 800 IU
- Unable or unwilling to communicate or answer questions
- Unwilling to sign informed consent
- Considered unsuitable for participation by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, China
Actively Recruiting
2
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
Research Team
G
Gang Liu, PHD
CONTACT
Y
Yuwei Lai, BM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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