Effect of Vitamin D3 on Functions of Kidney and Blood Vessels in Vitamin D Deficient Patients with Type 2 Diabetes Mellitus

A Randomized Double-Blind Placebo-Controlled Trial Evaluating the Efficacy of Oral Vitamin D3 in Improving Renal and Vascular Functions in Vitamin D Deficient Patients with Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010785

Enrollment

100

Registered

2017-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: null- Vitamin D deficient patients with type 2 diabetes mellitus

Interventions

Intervention1: Group 1: Oral vitamin D3 (cholecalciferol) 60,000 IU weekly for 8 weeks Control Intervention1: Group 2: Oral similar looking placebo weekly for 8 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender aged between 18 and 65 years with type 2 diabetes mellitus with or without hypertension and has stable clinical profile and receiving treatment >= 3 months. 2. Serum 25-hydroxy vitamin D level 3. Estimated GFR (eGFR) between 30 and 60 mL/min/1.73m2.

Exclusion criteria

Exclusion criteria: 1. Patient on vitamin D-based therapy within 6 months prior to screening. 2. Patients with symptomatic vitamin D deficiency 3. Patient with a history of allergy or sensitivity to vitamin D or its analogues. 4. Patient with blood pressure >= 160/100 mm Hg or 5. Patient with uncontrolled diabetes: fasting blood glucose > 200 mg/dL or post prandial blood glucose > 350 mg/dL or HBA1C > 10.5% 6. Patients with coexisting diseases, such as, chronic gastrointestinal disease, myocardial infarction, cerebrovascular accident, congestive heart failure, cardiomyopathies, peripheral vascular diseases, malignancies and renal stones. 7. Patient with history of any drug or alcohol abuse 8. Patient has received any investigational drug 9. Patient on any drugs modulating calcium metabolism and homeostasis.

Design outcomes

Secondary

Measure	Time frame
1. Estimated glomerular filtration rate (eGFR) 2. Inflammatory markers (hs-CRP, TNF-alpha, IL-6 and IL-10) 3. Parameters of vascular functions (blood pressure, brachial-ankle pulse wave velocity, arterial stiffness index, aortic pressures and augmentation index) 4. Patient-related adverse drug reactionsTimepoint: a) At baseline b) At end of treatment (end of 8 weeks) c) At end of follow-up (end of 24 weeks)	—

Measure

Time frame

1. Estimated glomerular filtration rate (eGFR) 2. Inflammatory markers (hs-CRP, TNF-alpha, IL-6 and IL-10) 3. Parameters of vascular functions (blood pressure, brachial-ankle pulse wave velocity, arterial stiffness index, aortic pressures and augmentation index) 4. Patient-related adverse drug reactionsTimepoint: a) At baseline b) At end of treatment (end of 8 weeks) c) At end of follow-up (end of 24 weeks)

—

Primary

Measure	Time frame
1. Urinary albumin creatinine ratio 2. Carotid-femoral pulse wave velocityTimepoint: a) At baseline b) At end of treatment (end of 8 weeks) c) At end of follow-up (end of 24 weeks)	—

Countries

India

Contacts

Public ContactDr Sadish Kumar Kamalanathan

Jawaharlal Institute of Postgraduate Medical Education and Research

sandhiyaselvarajan@gmail.com9443492922

Outcome results

None listed

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