NCT06553729

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

August 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

August 11, 2024

Last Update Submit

September 10, 2025

Conditions

Glucose Intolerance During Pregnancy

Keywords

Vitamin DPrebioticsGlucose Intolerance During PregnancyBlood GlucoseGestation diabetesAdverse pregnancy outcomes

Outcome Measures

Primary Outcomes (2)

  • Concentration of fasting blood glucose

    Concentration of fasting blood glucose, measured in mmol/L

    24-28 gestational weeks, 32-36 gestational weeks, and delivery

  • Glycated hemoglobin (HbA1c)

    Concentration of HbA1c, measured in the percentage of hemoglobin

    24-28 gestational weeks, 32-36 gestational weeks, and delivery

Secondary Outcomes (9)

  • Incidence of Gestational Diabetes

    24-28 gestational weeks

  • Concentration of blood lipids

    24-28 gestational weeks, 32-36 gestational weeks, and delivery

  • Concentration of plasma 25(OH)D

    24-28 gestational weeks, 32-36 gestational weeks, and delivery

  • Concentration of C-reactive protein (CRP)

    24-28 gestational weeks, 32-36 gestational weeks, and delivery

  • Concentration of interleukin-6 (IL-6)

    24-28 gestational weeks, 32-36 gestational weeks, and delivery

  • +4 more secondary outcomes

Study Arms (4)

Vitamin D3 + Prebiotics

ACTIVE COMPARATOR

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

Drug: Vitamin D3Dietary Supplement: Prebiotics

Vitamin D3 + Prebiotics placebo

ACTIVE COMPARATOR

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

Drug: Vitamin D3Dietary Supplement: Prebiotics placebo

Prebiotics +Vitamin D3 placebo

ACTIVE COMPARATOR

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

Dietary Supplement: PrebioticsDietary Supplement: Vitamin D3 placebo

Vitamin D3 placebo + Prebiotics placebo

PLACEBO COMPARATOR

Vitamin D3 placebo. Prebiotics placebo.

Dietary Supplement: Prebiotics placeboDietary Supplement: Vitamin D3 placebo

Interventions

Vitamin D3DRUG

Vitamin D3 (cholecalciferol), 1600 IU per day.

Also known as: Cholecalciferol
Vitamin D3 + PrebioticsVitamin D3 + Prebiotics placebo
PrebioticsDIETARY_SUPPLEMENT

Prebiotics (inulin), 10g per day.

Also known as: Inulin
Prebiotics +Vitamin D3 placeboVitamin D3 + Prebiotics
Prebiotics placeboDIETARY_SUPPLEMENT

Prebiotics placebo.

Vitamin D3 + Prebiotics placeboVitamin D3 placebo + Prebiotics placebo
Vitamin D3 placeboDIETARY_SUPPLEMENT

Vitamin D3 placebo

Prebiotics +Vitamin D3 placeboVitamin D3 placebo + Prebiotics placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify 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 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, and syphilis).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

MeSH Terms

Interventions

CholecalciferolPrebioticsInulin

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsDietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and BeveragesStarchGlucansBiopolymersPolymersMacromolecular SubstancesFructans

Study Officials

  • Gang Liu, PHD

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

    PRINCIPAL INVESTIGATOR

  • An Pan, PHD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Liu, PHD

CONTACT

86-15926238366liugang026@hust.edu.cn

Yuwei Lai, BM

CONTACT

86-13247125977laiyuwei918@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 14, 2024

Study Start

February 24, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)