Overview

Double-blind Randomized Controlled Trial Investigating the Effects of Calcitriol on Biomarkers in Diabetic Kidney Disease Patients

Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
Diabetic Kidney Disease (DKD) is a complication that occurs due to poor glycemic control over a long period. The decrease or loss of podocytes is an important index in determining the degree of glomerular damage. Previous studies in patients with DKD reported that vitamin D administration can improve their renal function through several mechanisms. However, there is still little evidence available regarding the effects of calcitriol on biomarkers of DKD. This trial is a double-blind randomized controlled trial to assess the effect of calcitriol in DKD patients through several biomarkers which reflect pathomechanism in DKD. Those biomarkers include urinary podocin, urinary nephrin, urinary KIM-1, urinary IL-6, plasma renin, and albuminuria. The primary outcome is any improvement on podocyte markers, tubular markers, kidney inflammation parameters, plasma renin, and albuminuria between calcitriol and placebo groups. Secondary outcomes include the relation between each marker and the side effects of intervention therapy.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indonesia University
Treatments:
Calcitriol
Criteria
Inclusion Criteria:

- Controlled type 2 diabetes mellitus with HbA1C at least <8% and albuminuria (UACR>30
mg/mmol)

- Estimated Glomerular Filtration Rate (eGFR) >45 ml/min/1.73 m2

- Agree to participate in the research

Exclusion Criteria:

- Uncontrolled hypertension with routine Angiotensin-converting-enzyme inhibitors (ACEi)
or Angiotensin II receptor blockers (ARBs) treatment

- Hypercalcemia (total serum Ca level >10/5 mg/dL)

- Hyperphosphatemia (total serum phosphate level >5 mg/dL)

- Hypersensitivity to calcitriol

- Suffering from other diseases that cause proteinuria

- Acute diseases

- Smoker or previous smoking history

- Taking medications or suplements that can affect calcitriol metabolism (thiazide,
digoxin, anti-convulsant)