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A Randomized Controlled Trial Comparing the Efficacy and Safety of Cholecalciferol versus Calcitriol in CKD-MBD Patients with Vitamin D deficiency.

A Randomized Controlled Trial Comparing the Efficacy and Safety of Cholecalciferol versus Calcitriol in CKD-MBD Patients with Vitamin D deficiency. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102705
Enrollment
66
Registered
2026-02-02
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: E559- Vitamin D deficiency, unspecified

Interventions

Intervention1: Safety and efficacy of Calcitriol vs Cholecalciferol in CKD-MBD patients: The proposed research introduces a novel comparative framework by conducting a randomized controlled trial spec

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: CKD Stage 3 to 5 (not on dialysis) Serum 25(OH) D levels less than 20ng/mL Clinical or biochemical evidence of CKD-MBD

Exclusion criteria

Exclusion criteria: Serum calcium more than 10.5 mg/dL Serum iPTH less than 15 pg/mL History of parathyroidectomy Presence of bone diseases unrelated to CKD (e.g., multiple myeloma, bone metastases) Use of immunosuppressive drugs Diagnosed immune-mediated disorders (e.g., systemic lupus erythematosus, sarcoidosis) Critically ill or moribund patients Malabsorption syndrome Sepsis Malignancy Pregnancy or lactation Patients unable to take oral medications Patients not providing consent

Design outcomes

Primary

MeasureTime frame
Rise or change in serum 25 hydroxy vitamin D and active 1,25 dihydroxy vitamin D levels at the 3 month point. The pattern of change in bone formation markers particularly, BS-ALP and Serum P1NP. How often patients experience elevated calcium or phosphate levels on either therapy. Whether intact parathyroid hormone (iPTH) levels show meaningful improvement with either treatment.Timepoint: 0,1,2,3 months—

Secondary

MeasureTime frame
To evaluate the change in bone turnover markers (BS-ALP and S-P1NP) over a period of 3 months 3 months. To determine the incidence of hypercalcemia and hyperphosphatemia in both treatment groups. To assess the change in serum intact parathyroid hormone (iPTH) levels from baseline to 3 months.Timepoint: 0, 1, 2, 3 months—

Countries

India

Contacts

Public ContactAman Chaudhary

PGIMER Chandigarh

Divyaveer.ss@gmail.com8017062986

Outcome results

None listed

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