Relationship between Vitamin D and Diabetic Microvascular Complication

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 - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063782

Enrollment

100

Registered

2024-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: group 3 , Vitamin D- cholecalciferol interventional group: people with diabetes and having any of the microvascular complication with vitamin D deficiency.Participants in the interventi

Eligibility

Inclusion criteria

Inclusion criteria: patient with diabetes and at least one microvascular complication and vitamin d deficiency

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 complicationTimepoint: 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	—

Measure

Time frame

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 complicationTimepoint: 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

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Secondary

Measure	Time frame
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)Timepoint: serum levels of vitamin D & AGE at baseline1 week & after 3 months intervention with genotyping of RAGE gene	—

Measure

Time frame

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)Timepoint: serum levels of vitamin D & AGE at baseline1 week & after 3 months intervention with genotyping of RAGE gene

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Countries

India

Contacts

Public Contactsaitharani arumugam

Chettinad Academy Of Research And Education

karpag@yahoo.com9840686686

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026