A clinical trial to study the effects of vitamin D and vitamin D plus alpha lipoic acid on cardiovascular complications in type 2 diabetes mellitus patients.

Assessment of biochemical markers of cardiovascular complications following vitamin D and vitamin D plus alpha lipoic acid supplementation in type 2 diabetes patients - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/05/005804

Enrollment

210

Registered

2015-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: null- Diabetes associated cardiovascular complications Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Vitamin D and alpha lipoic acid: Based on baseline vitamin D levels, patients requiring vitamin D will be prescribed by a qualified physcian and followed up to a period of 9 months. Alp

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus patients of duration 1 to 10 years with or without cardiovascular complications and not on insulin

Exclusion criteria

Exclusion criteria: Type 1 diabetic patients. Acutely ill diabetic patients. Type 2 diabetes patients of less than one year and more than 10 years duration. Patients who are on vitamin D, insulin and calcium supplements Type 2 diabetic patients with established renal and hepatic dysfunction

Design outcomes

Primary

Measure	Time frame
cardiovascular status in type 2 diabetes patients by way of biochemical markers based on their vitamin D levelsTimepoint: base line (0 month) vitamin D status and biochemical markers will be estimated. After 9 months of vitamin D supplementation their cardiovascular status will be reassessed by way of biochemical markers	—

Secondary

Measure	Time frame
To look for major adverse cardiac events (MACE) during the course of treatment.Timepoint: at 1 year	—

Countries

India

Contacts

Public ContactYalla DurgaRao

Kasturba Medical College

durgaraoyalla@gmail.com8277455197

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026