Vitamin D and prebiotic supplements to help control blood sugar in pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled trial enrolling about 500 pregnant people aged 18–45 at 6–15 weeks of gestation who are at high risk for gestational diabetes. Participants are randomly assigned to daily vitamin D3 (1600 IU), inulin prebiotic (10 g), or matching placebos and followed through pregnancy with regular blood glucose and metabolic monitoring. Eligible participants have a singleton pregnancy, local residency, and meet high-risk criteria such as pre-pregnancy BMI ≥24, prior GDM or family history, delivery of a macrosomic infant, or prediabetic laboratory values; those with existing diabetes or major medical exclusions are excluded. The study compares glucose control and related outcomes between supplement and placebo groups to see if these low-cost interventions improve gestational glycemic measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 6-15 weeks of gestation.
2. Age 18-45 years old.
3. Permanent resident or resident locally at least one year.
4. GDM high-risk pregnant women (meeting any of the following criteria):

   1. Pre-pregnancy body mass index (BMI) ≥24.0 kg/m2,
   2. History of GDM or a family history of diabetes,
   3. History of delivery of macrosomia (birth weight \>4000 g),
   4. HbA1c 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol/L.

Exclusion Criteria:

1. Multiple pregnancy.
2. Have received infertility treatment such as in vitro fertilization or intrauterine insemination.
3. 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%).
4. 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).
5. Severe liver disease (such as cirrhosis) or severe kidney disease (such as renal failure or requiring dialysis).
6. Kidney stones, hypercalcemia, hypercalciuria, parathyroid hormone abnormality.
7. Any mental disorders, such as schizophrenia, depression, other mental disorders, or bipolar disorder.
8. History of allergy or intolerance to vitamin D, chicory root, or starch.
9. Have participated in or are participating in other clinical trials within the past 3 months.
10. Daily vitamin D intake \>800 IU.
11. Inability or refusal to answer and communicate.
12. Those who are unwilling to sign the informed consent.
13. The researcher thinks that it is not suitable to participate in this research.

Where it's running

• Central People's Hospital of Zhanjiang
  Zhanjiang, Guangdong, China Recruiting
• Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Principal investigator: Gang Liu, PHD — School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Gang Liu, PHD
• Email: liugang026@hust.edu.cn
• Phone: 86-15926238366

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Early pregnancy lifestyle patterns and glucose changes in a TOFFFY sub-study

  This study tests whether daily patterns like sleep, activity, and meal timing in early pregnancy affect glucose levels and the risk of gestational diabetes, using CGM and wearable data in pregnant women in Singapore.

  Recruiting KK Women's and Children's Hospital · Singapore, Singapore · NCT07534670

• Reducing non-nutritive sweeteners during pregnancy and lactation

  This study is testing if cutting back on non-nutritive sweeteners during pregnancy and breastfeeding can improve health for both mothers and their babies.

  Recruiting George Washington University · Washington D.C., District of Columbia · NCT06548828

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.