Abstract: TH-OR029
Randomized Trial to Evaluate the Effect of Cholecalciferol Supplementation on Parathyroid Hormone in Hemodialysis Patients
Session Information
- CKD-MBD: Phosphorus, FGF-23, and Trials
October 25, 2018 | Location: 33C, San Diego Convention Center
Abstract Time: 06:06 PM - 06:18 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Sola, Laura, CASMU-IAMPP, Montevideo, Uruguay
- Gonzalez, Susana B., CASMU-IAMPP, Montevideo, Uruguay
- Diaz, Juan Carlos, CASMU-IAMPP, Montevideo, Uruguay
- Fleitas, Sandra Del luján, CASMU-IAMPP, Montevideo, Uruguay
- Bello, Manuela, CASMU-IAMPP, Montevideo, Uruguay
- Leyun, Maria noel, CASMU-IAMPP, Montevideo, Uruguay
- Hermo, Ricardo Antonio, CASMU-IAMPP, Montevideo, Uruguay
Background
Vitamin D (25VD) supplementation is associated with a decrease in parathyroid hormone (iPTH) in general population, not confirmed in hemodialysis (HD) patients (Pts).
The aim of the study was to evaluate if cholecalciferol supplementation can normalize 25VD levels and reduce iPTH in HD Pts with vitamin D deficiency.
Methods
Randomized, controlled trial with 2 arms: cholecalciferol vs placebo. Inclusion Criteria: Adult Pts, on HD for ≥ 3 months, 25VD < 30 ng/ml and iPTH >300 ng/ml. Randomization was done using a table of random numbers, and allocation was blinded for Pts and investigators.
Intervention: Pts received one tablet with 5000 IU 25VD or placebo during dialysis thrice a week for 12 weeks. Hemoglobin (Hb), Calcium (Ca), Phosphorous (P), erythropoietin dose (IU/kg/week), Alkaline Phosphatase (AP), 25VD and iPTH were measured at 0 and 12 weeks. Assuming a dropout rate of 15%, sample size of 120 Pts was needed for a 20% reduction on iPTH in 35% of treated Pts. Analysis was done per protocol for the primary outcome. Quantitative data was expressed were compared by t test and categorical by chi square. Significant differences were considered with p values <0.05. Institutional Ethics Committee authorization was obtained.
Results
118 Pts were randomized, 60 to 25VD and 58 to PLA with no significant differences (Table I). 17 Pts were lost of follow-up, 101 Pts completed treatment (54 with 25VD and 47 with PLA). Pts on 25VD normalized 25VD (increased x 20.9 ± 11.9) significantly more frequently than those on PLA (41 (75.9%) vs 11 (23.4%)) . A 20% iPTH reduction was seen in 17 Pts (29.3%) on 25VD (x reduction 45 ± 194) and 9 Pts (19.1%) on PLA (p=0.1). A reduction on AP was seen in 25VD Pts (29.5 ± 84.8, p=0.016) and not on PLA (21.9 ± 81.3).
Conclusion
Significant increase in 25VD was observed in treated group, with a reduction on AP but with no significant effect on iPTH
Table I. Baseline Characteristics of Pts
| 25 vitamin D (n=60) | placebo (n=58) | |
| Gender (M) % | 39 (65%) | 35 (60.3%) |
| Age ys x ± SD | 68.3 ±14.1 | 65.6 ±15.1 |
| Diabetics % | 24 (40%) | 20 (34.5) |
| AP mIU/ml x ± SD | 219 ± 180 | 234 ± 269 |
| 25 VD ng/ml x ± SD | 16.5 ± 7.6 | 16.9 ± 7.7 |
| PTH ng/ml x ± SD | 692 ± 387 | 623± 323 |
Funding
- Commercial Support – Celsiuss