Vitamin d and prebiotics may prevent pregnancy diabetes
NCT ID NCT06553729
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether taking vitamin D and prebiotics (inulin) during early pregnancy can help control blood sugar in women at high risk for gestational diabetes. 500 pregnant women will receive supplements or placebos from 6-15 weeks of pregnancy. The goal is to see if these simple additions can lower fasting glucose and HbA1c levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin D3 (cholecalciferol) and prebiotics (inulin)
- What this could lead to
- If it works, this could point toward a simple, safe way to prevent gestational diabetes in high-risk pregnancies.
- What could go wrong
- This is an early-stage trial with no phase, and the effects may be small or not clinically meaningful. Supplements may not prevent diabetes for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Central People's Hospital of Zhanjiang
RECRUITINGZhanjiang, Guangdong, China
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Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
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