POS-250 A RANDOMIZED TRIAL OF EFFECT OF CHOLECALCIFEROL SUPPLEMENTATION ON CARDIOVASCULAR DISEASE, INFLAMMATION, AND BONE METABOLISM MARKERS IN CKD: BASELINE CHARACTERISTICS OF FEASIBILITY PHASE

ABSTRACT

Introduction: Studies have linked lower vitamin D levels with cardiovascular disease (CVD) and mortality in general population and chronic kidney disease (CKD). The preliminary evidence of vitamin D supplementation is encouraging but there is a huge void with respect to good quality long term data supporting the use of this promising intervention for translation into better outcomes for CVD in CKD. This study is exploring the effect of cholecalciferol supplementation on cardiovascular disease, markers of inflammation and bone metabolism in CKD. We present the baseline characteristics of feasibility phase of the trial. Methods: The study is a multicentric, prospective, randomized, placebo controlled, double blind trial in two parallel groups and feasibility phase is being done at Postgraduate Institute of Medical Education and Research, Chandigarh, India. The trial is registered at Clinical Trials Registry of India (CTRI/2019/05/019211). After a run-in period of 2 weeks, the enrolled subjects are randomized in 11 to receive either 60,000 IU/2 weeks of cholecalciferol or matching placebo. The subjects will be then followed up every three month till 3 years. The primary outcome of the study is a composite of major adverse cardiac events (MACE). Secondary outcome measures include all-cause mortality, need of RRT, change in hsCRP, IL-6, iPTH, FGF-23, bone specific alkaline phosphatase, and CTX-1. Results: A total of 720 subjects have been screened till date. Out of 119 enrolled, 86 subjects have been randomized over 24 months period. 76% subjects have completed annual follow up at 12 months, 66% subjects - 15thmonths follow up, 40%- 18 months follow up, 26% subjects - 21 months follow up, 6% subjects – 24 months follow up. Baseline characteristics and serum biomarkers levels has been analysed in 80 subjects. Mean age of the subjects were 51.3 ± 12.2 years and 58.8 % were males. Serum haemoglobin levels were 11.6 ±1.7 g/dl. Mean eGFR was 26.3 (17.4, 35.1) ml/min/1.73m2. Outcome events were;MACE 1 (due to CVD), death other than due to MACE 1 (due to COVID 19), subjects with composite of all-cause death and non-fatal MACE 2, subject with need of RRT1 and subjects with composite of 50% decline in GFR or need of RRT 3. 2 serious adverse events unrelated to study drug were reported during the course of study. Table Baseline levels of various serum biomarkers [Formula presented] Conclusions: Despite COVID 19 related restrictions being in place for most of the last 18 months, the study has been able to screen and enrol participants. The follow ups have been ensured either through physical or remote (mobile/telephonic) means. Once in the multi-centric phase, the study will be able to test a relatively inexpensive intervention in the form of vitamin D supplementation for CVD in CKD. No conflict of interest