Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553729
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy a Randomized Double-Blind Placebo-Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 240 kgm2
2 History of GDM or a family history of diabetes
3 History of delivery of macrosomia birth weight 4000 g
4 Glycated hemoglobin HbA1c 57-64 or fasting blood glucose 56-70 mmolL 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 70 mmolL or HbA1c65 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
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 240 kgm2
2 History of GDM or a family history of diabetes
3 History of delivery of macrosomia birth weight 4000 g
4 Glycated hemoglobin HbA1c 57-64 or fasting blood glucose 56-70 mmolL 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 70 mmolL or HbA1c65 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None