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New treatment option for Glucose Intolerance During Pregnancy
Official title Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy
ClinicalTrials.gov ID: NCT06553729
What this study is testing
What is Vitamin D3?
Vitamin D3 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glucose intolerance during pregnancy.
Also referred to as Cholecalciferol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 6-15 weeks of gestation.
- Age 18-45 years old.
- Permanent resident or resident locally at least one year.
- GDM high-risk pregnant women (meeting any of the following criteria):
- Pre-pregnancy body mass index (BMI) ≥24.0 kg/m2,
You likely can't join if
- Multiple pregnancy.
- Have received infertility treatment such as in vitro fertilization or intrauterine insemination.
- History of diabetes or current diagnosis of diabetes (including type 1 and type 2 diabetes) or abnormal glucose tolerance at recruitment (fasting...
- Serious chronic diseases (including cardiovascular and cerebrovascular diseases, cancer, and thyroid dysfunction) or infectious diseases (including...
- Severe liver disease (such as cirrhosis) or severe kidney disease (such as renal failure or requiring dialysis).
- Kidney stones, hypercalcemia, hypercalciuria, parathyroid hormone abnormality.
See the full eligibility criteria
- 6-15 weeks of gestation.
- Age 18-45 years old.
- Permanent resident or resident locally at least one year.
- GDM high-risk pregnant women (meeting any of the following criteria):
- Pre-pregnancy body mass index (BMI) ≥24.0 kg/m2,
- History of GDM or a family history of diabetes,
- History of delivery of macrosomia (birth weight \>4000 g),
- HbA1c 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol/L.
- Multiple pregnancy.
- Have received infertility treatment such as in vitro fertilization or intrauterine insemination.
- 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%).
- Serious chronic diseases (including cardiovascular and cerebrovascular diseases, cancer, and thyroid dysfunction) or infectious diseases (including hepatitis B, active tuberculosis, acquired immunodeficiency syndrome...
- Severe liver disease (such as cirrhosis) or severe kidney disease (such as renal failure or requiring dialysis).
- Kidney stones, hypercalcemia, hypercalciuria, parathyroid hormone abnormality.
- Any mental disorders, such as schizophrenia, depression, other mental disorders, or bipolar disorder.
- History of allergy or intolerance to vitamin D, chicory root, or starch.
- Have participated in or are participating in other clinical trials within the past 3 months.
- Daily vitamin D intake \>800 IU.
- Inability or refusal to answer and communicate.
- Those who are unwilling to sign the informed consent.
- The researcher thinks that it is not suitable to participate in this research.
The study team makes the final eligibility decision.
Where it's taking place
- Zhanjiang, Guangdong, China
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhanjiang, Guangdong, China; Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.