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

Phase 4

Completed

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

• Registration Number: CTRI/2017/12/010785
• Lead Sponsor: Intramural fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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 < 20 ng/ml.

3.Estimated GFR (eGFR) between 30 and 60 mL/min/1.73m2.

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 < 80/60 mm Hg.

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 <= 6 months prior to the screening.

8.Patient has received any investigational drug <= 3 months prior to this study.

9.Patient on any drugs modulating calcium metabolism and homeostasis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Urinary albumin creatinine ratio <br/ ><br>2. Carotid-femoral pulse wave velocityTimepoint: a) At baseline <br/ ><br>b) At end of treatment (end of 8 weeks) <br/ ><br>c) At end of follow-up (end of 24 weeks)

Secondary Outcome Measures

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