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 K1) with menadione (water soluble vitamin K or vitamin K3) in prevention of subclinical vitamin K deficiency.


METHODS
A doubleblind randomized controlled trial.


METHODS
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 detectable 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% (41/85) neonates in Group I and 44.7%(38/85) neonates in Group II had detectable PIVKAII 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.


CONCLUSIONS
Comparable PIVKAII detection rate and PIVKAII levels in neonates receiving phytomenadione or menadione indicate their similar efficacy in prevention of vitamin K deficiency. However, high PIVKAII detection rate observed with both preparations indicates recent vitamin K deficiency and may be due to either inadequate dose of vitamin K or persistence of PIVKAII of fetal origin.
Chawla
D
D
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110 029, India.
Deorari
A K
AK
Saxena
R
R
Paul
V K
VK
Agarwal
R
R
Biswas
A
A
Meena
A
A
D015415:Biomarkers / Q000097:blood; D006801:Humans; D007231:Infant, Newborn; D011498:Protein Precursors / Q000097:blood; D011516:Prothrombin; D010837:Vitamin K 1 / Q000627:therapeutic use*; D024483:Vitamin K 3 / Q000627:therapeutic use*; D014813:Vitamin K Deficiency / Q000175:diagnosis / Q000517:prevention & control*; D014815:Vitamins / Q000627:therapeutic use*
D015415:Biomarkers; D011498:Protein Precursors; D014815:Vitamins; C008208:acarboxyprothrombin; D024483:Vitamin K 3; D010837:Vitamin K 1; D011516:Prothrombin