Prophylactic oral calcium–vitamin
D3
–magnesium supplementation reduced citrate‐related reactions during peripheral blood stem cell collection in healthy donors: A randomized controlled trial
Keiko Fujii, Toshiharu Mitsuhashi, Hiroko Sainoki, Yuuka Tanaka, Joji Shimono, Hiroyuki Murakami, Fumio Otsuka, Yoshinobu Maeda, Nobuharu Fujii Abstract
Background
Citrate‐related reactions remain the most common adverse events during peripheral blood stem cell (PBSC) collection despite routine prophylactic intravenous calcium administration. We evaluated whether prophylactic oral calcium–vitamin D3–magnesium supplementation reduces citrate‐related reactions in healthy PBSC donors.
Study Design and Methods
In this prospective open‐label randomized controlled trial, 52 healthy allogeneic PBSC donors were randomly assigned to receive prophylactic oral calcium–vitamin D3–magnesium supplementation before PBSC collection ( n = 26) or no oral supplementation ( n = 26). The primary endpoint was Grade ≥1 citrate‐related reactions. Secondary endpoints included Grade ≥2 reactions, electrolyte‐related outcomes, and safety.
Results
All randomized donors completed the study and were included in the final analysis. Grade ≥1 citrate‐related reactions occurred in 8 of 26 donors (30.8%) in the control group and in none of the intervention group (RR, 0.000; 95% CI, 0.000–0.000; p < .001). Grade ≥2 reactions occurred in two donors (7.7%) in the control group and in none of the intervention group. One donor in the control group developed Grade 4 tetany near the end of PBSC collection, after which the procedure was terminated. No Grade 4 reactions occurred in the intervention group. No statistically significant between‐group differences were observed in electrolyte‐related outcomes.
Conclusion
Prophylactic oral calcium–vitamin D3–magnesium supplementation markedly reduced citrate‐related reactions during PBSC collection in healthy donors and may represent a practical approach to improving donor safety.