Actively Recruiting
Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Led by Huazhong University of Science and Technology · Updated on 2025-09-16
500
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether taking vitamin D or prebiotics during pregnancy can help control blood sugar levels in women at high risk for gestational diabetes mellitus (GDM). It is a randomized, double-blind, placebo-controlled trial including about 500 pregnant women aged 18 to 45 years who are between 6 and 15 weeks of pregnancy and meet specific risk criteria for GDM, such as high body mass index, family history of diabetes, or previous pregnancy complications. Participants will be randomly assigned to one of four groups: vitamin D plus prebiotics, vitamin D plus prebiotics placebo, prebiotics plus vitamin D placebo, or double placebo. They will take daily capsules and powders containing either the active supplements or placebos until delivery. The study includes three follow-up visits during pregnancy at 24-28 weeks, 32-36 weeks, and at delivery to monitor progress and collect samples. During these visits, researchers will measure height, weight, blood pressure, blood sugar, vitamin D levels, inflammatory markers, and gut bacteria. Blood, urine, and stool samples will be collected for analysis. The main outcomes are fasting blood glucose and glycated hemoglobin (HbA1c) levels. Secondary outcomes include GDM incidence, blood lipids, delivery details, and pregnancy complications. This monitoring will continue through delivery to assess the impact of the supplements on glucose control and pregnancy outcomes.
CONDITIONS
Brief 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 living locally for at least one year
- High risk of gestational diabetes defined by any of the following:
- Pre-pregnancy body mass index (BMI) 24.0 kg/m2 or higher
- History of gestational diabetes or family history of diabetes
- History of delivering a baby over 4000 grams
- HbA1c between 5.7% and 6.4% or fasting blood glucose between 5.6 and 7.0 mmol/L
- Singleton pregnancy
- No infertility treatment
- No current diabetes or impaired glucose tolerance at recruitment
- No allergy to chicory root or vitamin D
- Agreement to limit use of vitamin D, prebiotics, probiotics, or synbiotic supplements during study
- Ability to access study centers conveniently
You will not qualify if you...
- Multiple pregnancy (twins or more)
- Received infertility treatments like in vitro fertilization or intrauterine insemination
- History or current diagnosis of diabetes or abnormal glucose tolerance (fasting blood glucose over 7.0 mmol/L or HbA1c 6.5% or higher)
- Serious chronic diseases such as cardiovascular, cerebrovascular diseases, cancer, or thyroid problems
- Infectious diseases including hepatitis B, active tuberculosis, AIDS, or syphilis
- Severe liver or kidney disease
- Kidney stones, calcium metabolism disorders, or parathyroid hormone abnormalities
- Mental disorders including schizophrenia, depression, bipolar disorder, or others
- 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
- Inability or refusal to communicate or answer questions
- Unwillingness to sign informed consent
- Considered unsuitable for participation by the researcher
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 6-15 weeks of gestation until delivery
Participants take daily vitamin D or placebo capsules and prebiotics or placebo powder until delivery. They complete baseline questionnaires and have physical measurements and samples collected at enrollment and during follow-up visits.
1 baseline visit and 3 follow-up visits during pregnancy
Duration - Throughout pregnancy after treatment begins
Participants are monitored at follow-up visits during pregnancy at 24-28 weeks, 32-36 weeks gestation, and at delivery for blood tests, physical measurements, and pregnancy outcomes.
3 visits during pregnancy
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
Y
Yuwei Lai, BM
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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