Abstract: FR-PO973
Effects of Three Months of Ergocalciferol Supplementation in Patients with Stages 3 and 4 CKD: Results from a Randomized Clinical Trial
Session Information
- CKD Interventions: Trials and Quality Improvement
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Gudino, Paola, New York City Health and Hospitals Jacobi, Bronx, New York, United States
- Jim, Belinda, New York City Health and Hospitals Jacobi, Bronx, New York, United States
- Sokol, Seth I., New York City Health and Hospitals Jacobi, Bronx, New York, United States
- Coco, Maria, Montefiore Medical Center, New York, New York, United States
- Raff, Amanda C., Montefiore Medical Center, New York, New York, United States
- Hamadeh, Zaher, Montefiore Medical Center, New York, New York, United States
- Lo, Yungtai, Montefiore Medical Center, New York, New York, United States
- Johns, Tanya S., Montefiore Medical Center, New York, New York, United States
- Abramowitz, Matthew K., Montefiore Medical Center, New York, New York, United States
- Hostetter, Thomas H., Montefiore Medical Center, New York, New York, United States
- Melamed, Michal L., Montefiore Medical Center, New York, New York, United States
Background
Patients with chronic kidney disease (CKD) have higher prevalence of vitamin D deficiency. This is associated with albuminuria but clinical studies have shown mixed results. This randomized, placebo-controlled, double-blind clinical trial hypothesized that supplementation with ergocalciferol would decrease albuminuria in participants with CKD stages 3 and 4.
Methods
74 participants were assigned to either oral ergocalciferol 50,000 IU or placebo weekly for 8 to 12 weeks depending on baseline 25 hydroxyvitamin D (25OHD) levels. The primary outcome was change in albuminuria. Secondary outcomes included change in laboratory values serum 25 hydroxy vitamin D (25-OH-D), 1,25-dihydroxy vitamin D (1,25OH2D), calcium, phosphate, intact PTH (iPTH), fibroblast growth factor 23 (FGF-23), estimated GFR levels, emergency department (ED) visits and hospitalizations.
Results
Mean age of participants was 58 years (standard deviation (SD): 13 years). The participants were 43% female, 48% Hispanic, 38% non-Hispanic Black. 68% had CKD stage 3 at enrollment. There was no significant difference in the change in albuminuria between the groups (Placebo group: 437 mg/gm [IQR 158-1256] at baseline, 580 mg/gm [IQR 175-1160] at 12 weeks; Ergocalciferol group: 829 mg/gm [IQR 244-1942] at baseline, 850 mg/gm [IQR 137-1405] at 12 weeks; p value= 0.13). Analysis of secondary outcomes showed significant differences in 25(OH)D levels at 12 weeks placebo 16.6 ng/mL (SD 7.8) versus ergocalciferol group 29.4 ng/mL (SD 13.4) (p<0.001) and mean eGFR (Placebo: 36.7 (SD 13.4) at baseline and 37.6 (SD 16.2) at 12 weeks; Ergocalciferol group: 37.7 (SD 14.3) at baseline and 30.5 (SD 12.3) at 12 weeks; p=0.001). There was no difference in 1,25OH2D, calcium, phosphate, intact PTH or FGF-23 between the groups. Participants in the ergocalciferol group had fewer hospitalizations and ED visits (seventeen) versus the participants treated with placebo (twenty-seven).
Conclusion
Among non-Hispanic Black and Hispanic adults with CKD stage 3 or 4, supplementation with ergocalciferol resulted in no significant difference in albuminuria levels and mineral metabolism markers. However, eGFR significantly decreased at 12 weeks after treatment with ergocalciferol.
Funding
- NIDDK Support