Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351566
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-03-08
Brief Title:
Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Sponsor:
Huazhong University of Science and Technology
Organization:
Huazhong University of Science and Technology
Study Overview
Official Title:
Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes A Randomized Double-Blind Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 1600 IU or prebiotics inulin 10 gram has beneficial effects on cardiovascular disease risk factors
Detailed Description:
The goal of this randomized double-blind placebo-controlled trial with a two-by-two factorial design in individuals with type 2 diabetes T2D is to investigate whether taking daily dietary supplements of vitamin D3 1600 IU or prebiotics inulin 10 gram has beneficial effects on cardiovascular disease CVD risk factors
About 200 subjects with T2D will be included in this study All participants will provide written informed consent before randomization Eligible participants must have no history of cancer macrovascular or microvascular complications at trial entry and they are required to agree to limited use of vitamin D prebiotics probiotics or synbiotic supplementations as well as to convenient access to study centers Safety exclusions include renal failure or dialysis cirrhosis history of hypercalcemia or other conditions that would preclude participation
Eligible participants will be assigned by chance to one of four groups 1 daily vitamin D3 1600 IU and prebiotics 10 grams 2 daily vitamin D3 1600 IU and prebiotics placebo 10 grams 3 daily vitamin D3 placebo and prebiotics 10 grams or 4 daily vitamin D3 placebo 1600 IU and prebiotics placebo 10 grams Randomization will be computer-generated within sex and age groups
During the run-in period baseline questionnaires will be designed to collect data on sociodemographic factors lifestyle habits health status and medical conditions and participants will undergo physical measurements at baseline Blood urine and faeces samples will also be obtained at study centers
Participants in all groups will be required to take two capsules each day containing either vitamin D3 or vitamin D3 placebo as well as a strip of prebiotics powder 10 g per strip brew with warm water or prebiotics placebo Participants will receive their capsules and powder at study centers each month
Participants will complete follow-up questionnaires including information on adherence to trial regimens outside use of supplementations development of major illnesses and potential side effects of the trial agents at 3 months and 6 months after randomization Physical measurements and collection of biological samples will be conducted at study centers 6 months after randomization
The primary outcomes including glycated hemoglobin HbA1c and blood lipids such as total cholesterol triglycerides low-density lipoprotein cholesterol high-density lipoprotein cholesterol will be measured using blood samples The data will be collected and analyzed
About 200 subjects with T2D will be included in this study All participants will provide written informed consent before randomization Eligible participants must have no history of cancer macrovascular or microvascular complications at trial entry and they are required to agree to limited use of vitamin D prebiotics probiotics or synbiotic supplementations as well as to convenient access to study centers Safety exclusions include renal failure or dialysis cirrhosis history of hypercalcemia or other conditions that would preclude participation
Eligible participants will be assigned by chance to one of four groups 1 daily vitamin D3 1600 IU and prebiotics 10 grams 2 daily vitamin D3 1600 IU and prebiotics placebo 10 grams 3 daily vitamin D3 placebo and prebiotics 10 grams or 4 daily vitamin D3 placebo 1600 IU and prebiotics placebo 10 grams Randomization will be computer-generated within sex and age groups
During the run-in period baseline questionnaires will be designed to collect data on sociodemographic factors lifestyle habits health status and medical conditions and participants will undergo physical measurements at baseline Blood urine and faeces samples will also be obtained at study centers
Participants in all groups will be required to take two capsules each day containing either vitamin D3 or vitamin D3 placebo as well as a strip of prebiotics powder 10 g per strip brew with warm water or prebiotics placebo Participants will receive their capsules and powder at study centers each month
Participants will complete follow-up questionnaires including information on adherence to trial regimens outside use of supplementations development of major illnesses and potential side effects of the trial agents at 3 months and 6 months after randomization Physical measurements and collection of biological samples will be conducted at study centers 6 months after randomization
The primary outcomes including glycated hemoglobin HbA1c and blood lipids such as total cholesterol triglycerides low-density lipoprotein cholesterol high-density lipoprotein cholesterol will be measured using blood samples The data will be collected and analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None