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

Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

This trial will test whether taking daily vitamin D or a prebiotic supplement can help control blood sugar in pregnant people at high risk for gestational diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Locations: 2 sites (Zhanjiang, Guangdong and 1 other locations)
• Trial ID: NCT06553729 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are pregnant people aged 18–45 at 6–15 weeks gestation with a singleton pregnancy who are local residents and meet at least one high-risk criterion for GDM (BMI ≥24, prior GDM or family history of diabetes, prior macrosomia, or prediabetic HbA1c/fasting glucose).

Not a fit: People with an existing diagnosis of diabetes or abnormal glucose tolerance at recruitment, multiple pregnancy, serious chronic or infectious diseases, or allergies to chicory root (inulin) are unlikely to benefit or be eligible for this study.

Why it matters

Potential benefit: If successful, these inexpensive supplements could improve blood sugar control during pregnancy and reduce the risk of gestational diabetes and its complications.

How similar studies have performed: Previous studies of vitamin D or prebiotics for glucose control have shown mixed but sometimes promising results, so this trial builds on limited and not yet definitive evidence.

Eligibility criteria

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 this trial is running

Zhanjiang, Guangdong and 1 other locations

• 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

Conditions Glucose Intolerance During Pregnancy; Vitamin D; Prebiotics; Blood Glucose; Gestation diabetes; Adverse pregnancy outcomes