Vitamin k1 versus vitamin K3 for prevention of subclinical vitamin deficiency:: A randomized controlled trial

Objective: To compare efficacy of intramuscular phytomenadione (fat soluble vitamin K or vitamin K-1) with menadione (water soluble vitamin K or vitamin K-3) in prevention of subclinical vitamin K deficiency. Design: A double-blind randomized controlled trial. Settings: Tertiary care hospital. Methods: Healthy term neonates were randomized to receive 1 mg of either phytomenadione (Group I, n=85) or menadione (Group II, n=85) intramuscularly within 2 hours of birth. PIVKA-II, a sensitive and specific marker of vitamin K deficiency was measured by ELISA method (Diagnostica Stago, France). Plasma level > 2 ng/mL was labeled as delectable PIVKA-II. Results: Birth weight (2914 +/- 318 vs 2958 +/- 312 g), gestation (38.4 +/- 1.2 vs 38.4 +/- 1.0 wk) and other baseline variables were comparable between the two groups. 48.2% (41185) neonates in Group I and 44.7% (38185) neonates in Group II had 'detectable' PIVKA-II levels ([Relative Risk (95% confidence interval): 1.1 (0.8-1.5): P=0.76]). Median PIVKA-II levels in Group I and Group II were 1.99 ng/mL, and 1.97 ng/mL respectively (P=0. 26). At 72 +/- 12 h of age, mean packed cell volume and mean serum bilirubin levels were comparable in the two groups. Conclusion: Comparable PIVKA-II detection rate and PIVKA-II levels in neonates receiving phytomenadione or menadione indicate their similar efficacy in prevention of vitamin K deficiency. However, high PIVKA-II detection rate observed with both preparations indicates recent vitamin K ficiency and may be due to either inadequate dose of vitamin K or persistence of PIVKA-II of fetal origin.