| CTRI Number |
CTRI/2024/03/063782 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Relationship between Vitamin D and Diabetic Microvascular Complication |
|
Scientific Title of Study
|
EXPLORING THE INTERPLAY BETWEEN VITAMIN D DEFICIENCY, ADVANCED
GLYCATION END PRODUCT AND GENETIC VARIANT OF RAGE GENE IN PATIENT
WITH MICROVASCAULAR COMPLICATION: AN INTERVENTIONAL STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
saitharani arumugam |
| Designation |
Research Scholar |
| Affiliation |
Chettinad Academy Of Research And Education |
| Address |
Ground floor, right wing , Department Of Biochemistry, Chettinad Academy Of Research And Education, CHRI, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai-603103
Ground floor, right wing , Department Of Biochemistry, Chettinad Academy Of Research And Education, CHRI, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai-603103
Chennai
TAMIL NADU
603103
India |
| Phone |
8248789873 |
| Fax |
|
| Email |
saitharani1007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.L.Karpagavel |
| Designation |
professor & HOD |
| Affiliation |
Chettinad Academy Of Research And Education |
| Address |
Ground floor, right wing , Department Of Biochemistry, Chettinad Academy Of Research And Education, CHRI, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai-603103
Ground floor, right wing , Department Of Biochemistry, Chettinad Academy Of Research And Education, CHRI, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai-603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9840686686 |
| Fax |
|
| Email |
karpag@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
saitharani arumugam |
| Designation |
Research Scholar |
| Affiliation |
Chettinad Academy Of Research And Education |
| Address |
Ground floor, right wing , Department Of Biochemistry, Chettinad Academy Of Research And Education, CHRI, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai-603103
Ground floor, right wing , Department Of Biochemistry, Chettinad Academy Of Research And Education, CHRI, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai-603103
Chennai
TAMIL NADU
603103
India |
| Phone |
8248789873 |
| Fax |
|
| Email |
saitharani1007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute & CARE |
|
|
Primary Sponsor
|
| Name |
Chettinad Academey of Research and Education |
| Address |
Chettinad Health city, Rajiv Gandhi salai, Kelambakkam, chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrLKarpagavel |
Chettinad Hospital and Research Institute |
Ground floor, Department of biochemistry, CARE, Chettinad health city, Rajiv Gandhi road,chennai-603103
Chennai
TAMIL NADU |
9840686686
karpag@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad academy of research and education- INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
group 1, control group |
normal healthy individual without diabetes and will not receive any intervention |
| Comparator Agent |
group 2,reference group |
people with diabetes without microvascular complication receiving no intervention |
| Intervention |
group 3 , Vitamin D- cholecalciferol interventional group |
people with diabetes and having any of the microvascular complication with vitamin D deficiency.Participants in the intervention group will receive oral loading dose of 60,000 IU/WEEK and maintaining dose of 1500/d IU of Vitamin D supplementation daily for a duration of 3 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient with diabetes and at least one microvascular complication and vitamin d deficiency |
|
| ExclusionCriteria |
| Details |
patient with renal diseases or other conditions affecting vitamin D metabolism, osteoporosis, increased risk of fractures, muscle weakness, and a compromised immune system, use of vitamin D supplementation within the past 3 months, any hypersensitivity to study medication or contraindication
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this interventional study could be the change in microvascular complications (such as diabetic retinopathy, nephropathy, or neuropathy) severity or progression in patients with comorbid vitamin D deficiency, advanced glycation end product (AGE) accumulation, and a genetic variant of the RAGE gene. This could be measured using established clinical scales or diagnostic tests specific to each microvascular complication |
Serum levels of vitamin D measured in ng/mL at baseline1 week and after 3 months which might explore a new relationship between vitamin D and the microvascular complication of Diabetes mellitus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in serum levels of vitamin D before & after intervention.
Change in levels of advanced glycation end products (AGEs) in serum or affected tissues before & after intervention.
Change in expression or activity of the RAGE gene & its variants before & after intervention.
Improvement in overall glycemic control as measured by changes in HbA1c levels.
Improvement in microvascular endothelial function assessed through non-invasive techniques such as flow-mediated dilation.
Change in inflammatory markers associated with microvascular complications before & after intervention.
Improvement in quality of life measures related to microvascular complications
Incidence of adverse events related to the intervention (e.g., hypercalcemia or other side effects of vitamin D supplementation) |
serum levels of vitamin D & AGE at baseline1 week & after 3 months intervention with genotyping of RAGE gene |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
06/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/12/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This quasi-experimental ,
non-randomized, open-label, multicentered, single-arm non-inferiority interventional
cohort trial with enrichment study investigated the effect of vitamin D supplementation on Advanced Glycation End-products (AGEs) in diabetic patients with microvascular complications. The study enrolled 150 participants divided into three groups: 50 healthy controls (Group I), 50 diabetics without complications (Group II), and 50 diabetics with complications and vitamin D deficiency (Group III). Only the intervention group (Group III) received oral Vitamin D3 supplementation for three months. The primary outcome was the change in serum AGE levels in Group III after supplementation. All participants underwent baseline measurements of Vitamin D and AGE levels, as well as genotyping for the RAGE gene variant (rs1800625). The study also aimed to analyze associations between baseline Vitamin D and AGEs, and to investigate if the RAGE genotype influenced the response to supplementation. The protocol received ethical approval and informed consent was obtained from all participants. |