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Efficacy of calcitriol therapy in CKD, based on Vitamin D receptor gene polymorphisms

Evaluation of the role of vitamin D receptor (VDR) polymorphisms on efficacy of calcitriol therapy in stage 3 to 5 chronic kidney disease (CKD): a prospective double-blind study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026536
Enrollment
250
Registered
2020-07-13
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: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe) Health Condition 3: N185- Chronic kidney disease, stage 5

Interventions

None listed

Sponsors

Indian Council of Medical Research ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 250 adult patients (18 to 65yrs) with CKD (stages 3, 4 and 5; not on dialysis) would be enrolled for the study after informed consent for this study. CKD is defined as deranged renal function for more than 3 months with/without evidence of proteinuria. Staging of CKD would be done as per KDOQI guidelines using eGFR by Modification of diet in renal disease (MDRD) formula.

Exclusion criteria

Exclusion criteria: Patients already on vitD replacement therapy would be excluded. Any other co-morbidities requiring vitD supplementation would be excluded from the study.

Design outcomes

Primary

MeasureTime frame
the response to calcitriol therapy would be evaluated in terms of percentage of patients achieving 25% and 50% lowering in PTH levels following institution of calcitriol therapy.Timepoint: At the end of 3 months and 6 months.

Secondary

MeasureTime frame
FGF23 and Klotho would simultaneously be monitored for their appropriateness for development of early biomarkers for evaluating the efficacy of vitD therapy.Timepoint: At the end of 3 months and 6 months.

Countries

India

Contacts

Public ContactSudip Kumar Datta

All India Institute of Medical Sciences, New Delhi

dr.sudipdatta@gmail.com011-26594629

Outcome results

None listed

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