Health TrialsbyHealthPanel

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

ConditionGlucose Intolerance During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHuazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

6-15 weeks of gestation.

Age 18-45 years old.

Permanent resident or resident locally at least one year.

Pre-pregnancy body mass index (BMI) ≥24.0 kg/m2,

Disqualifiers

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).

Trial design

Design model

Factorial

Treatments tested in this trial

  • Vitamin D3

    Drug

    Vitamin D3 (cholecalciferol), 1600 IU per day.

  • Prebiotics

    Dietary supplement

    Prebiotics (inulin), 10g per day.

  • Prebiotics placebo

    Dietary supplement

    Prebiotics placebo.

  • Vitamin D3 placebo

    Dietary supplement

    Vitamin D3 placebo

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: Vitamin D3 + PrebioticsActive comparator 2 interventions
Group B: Vitamin D3 + Prebiotics placeboActive comparator 2 interventions
Group C: Prebiotics +Vitamin D3 placeboActive comparator 2 interventions
Group D: Vitamin D3 placebo + Prebiotics placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Concentration of fasting blood glucose

Concentration of fasting blood glucose, measured in mmol/L

Time frame
24-28 gestational weeks, 32-36 gestational weeks, and delivery
2

Glycated hemoglobin (HbA1c)

Concentration of HbA1c, measured in the percentage of hemoglobin

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

Secondary outcomes

1

Incidence of Gestational Diabetes

75g oral glucose tolerance test (OGTT) will be performed at 24-28 weeks of gestation to diagnose gestational diabetes

Time frame
24-28 gestational weeks
2

Concentration of blood lipids

Concentration of blood lipids (total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), measured in mmol/L

Time frame
24-28 gestational weeks, 32-36 gestational weeks, and delivery
3

Concentration of plasma 25(OH)D

Concentration of plasma 25(OH)D concentrations, measured in nmol/L

Time frame
24-28 gestational weeks, 32-36 gestational weeks, and delivery
4

Concentration of C-reactive protein (CRP)

Concentration of CRP, measured in mg/dL

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov
Apply now