Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy

NCT ID: NCT06553729

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

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.

About 500 pregnant women aged 18-45 years, at 6-15 weeks of gestation, had resided locally for at least one year, with high risk of GDM will be enrolled in the study. Pregnant women at high risk of GDM are defined as 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. Glycated hemoglobin (HbA1c) 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol/L; Eligible participants must have singleton pregnancy, no infertility treatment, no history of diabetes or a definite diagnosis of diabetes, or impaired glucose tolerance at recruitment (fasting blood glucose >7.0 mmol/L or HbA1c≥6.5%), no allergic history of chicory root and they will be required to agree to limit the use of vitamin D, prebiotics, probiotics, or synbiotic supplementations and to be convenient access to study centers. Safety exclusions include serious chronic or infectious diseases, serious liver or kidney disease, abnormalities in calcium metabolism, and clinically diagnosed mental disorders, or other conditions that would preclude participation.

Eligible participants will be assigned by chance to one of four groups: (1) daily vitamin D (1600 IU) and prebiotics (10 gram); (2) daily vitamin D (1600 IU) and prebiotics placebo; (3) daily vitamin D placebo and prebiotics (10 gram); or (4) daily vitamin D placebo and prebiotics placebo. Randomization will be conducted.

At enrollment, baseline questionnaires are designed to collect data on sociodemographic factors, pregnancy-related information, lifestyle habits, health status, and medical conditions before and during pregnancy. Participants in all groups will take two capsules that contained either vitamin D or vitamin D placebo and a strip of prebiotics powder (10 g per strip, brew with warm water and take with meals) or prebiotics placebo each day until delivery.

Participants will be followed up three times during pregnancy (24-28 weeks gestation, 32-36 weeks gestation and delivery), and receive a single stage-specific dosage at any given follow-up time.

Participants will have physical measurements of height, weight, other anthropometric measurements, and blood pressure at baseline and each follow-up visit. Blood, urine, and stool samples will also be obtained in the study center, fasting blood glucose, HbA1c and other biochemical indicators will also be detected at the same time, and a 75g oral glucose tolerance test (OGTT) will be measured during 24-28 weeks of gestation to diagnose GDM.

The primary outcomes, including fasting blood glucose and HbA1c will be measured using blood samples.

Secondary outcomes in this study include incidence of GDM, changes in blood lipids (such as total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), trends in plasma vitamin D levels, inflammatory factors, intestinal flora related indicators, delivery mode, incidence of preeclampsia and adverse pregnancy outcomes. Data will be collected and analyzed.

Conditions

Glucose Intolerance During Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D3 + Prebiotics

Vitamin D3 (cholecalciferol), 1600 IU per day. Prebiotics (inulin), 10g per day.

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DRUG

Vitamin D3 (cholecalciferol), 1600 IU per day.

Prebiotics

Intervention Type: DIETARY_SUPPLEMENT

Prebiotics (inulin), 10g per day.

Vitamin D3 + Prebiotics placebo

Vitamin D3 (cholecalciferol), 1600 IU per day. Prebiotics placebo.

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DRUG

Vitamin D3 (cholecalciferol), 1600 IU per day.

Prebiotics placebo

Intervention Type: DIETARY_SUPPLEMENT

Prebiotics placebo.

Prebiotics +Vitamin D3 placebo

Prebiotics (inulin), 10g per day. Vitamin D3 placebo.

Group Type: ACTIVE_COMPARATOR

Prebiotics

Intervention Type: DIETARY_SUPPLEMENT

Prebiotics (inulin), 10g per day.

Vitamin D3 placebo

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 placebo

Vitamin D3 placebo + Prebiotics placebo

Vitamin D3 placebo. Prebiotics placebo.

Group Type: PLACEBO_COMPARATOR

Prebiotics placebo

Intervention Type: DIETARY_SUPPLEMENT

Prebiotics placebo.

Vitamin D3 placebo

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 placebo

Interventions

Vitamin D3

Vitamin D3 (cholecalciferol), 1600 IU per day.

Intervention Type: DRUG

Prebiotics

Prebiotics (inulin), 10g per day.

Intervention Type: DIETARY_SUPPLEMENT

Prebiotics placebo

Prebiotics placebo.

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 placebo

Vitamin D3 placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Cholecalciferol; Inulin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

An Pan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gang Liu, PHD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

An Pan, PHD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

Locations

Central People's Hospital of Zhanjiang

Zhanjiang, Guangdong, China

Site Status: RECRUITING

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Gang Liu, PHD

Role: CONTACT

liugang026@hust.edu.cn

86-15926238366

Yuwei Lai, BM

Role: CONTACT

laiyuwei918@163.com

86-13247125977

Facility Contacts

Xingyue Song

Role: primary

18040520787

Yuwei Lai

Role: primary

13247125977

Other Identifiers

VD, Prebiotics in Pregnancy

Identifier Type: -

Identifier Source: org_study_id