Vitamin K1 versus Vitamin K3 for Prevention of Subclinical Vitamin Deficiency: A Randomized Controlled Trial.

Author(s): Chawla D, Deorari AK, Saxena R, Paul VK, Agarwal R, Biswas A, Meena A

Affiliation(s): Departments of Pediatrics and Hematology, All India Institute of Medical Sciences, New Delhi 110 029, India. Correspondence to: Dr A.K. Deorari, Professor, Division of Neonatology, Department of Pediatrics, WHO Collaborating Center for Training and Research in Newborn Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110 029, India. ashokdeorari_56@hotmail.com.

Publication date & source: 2007-11-07, Indian Pediatr., 44(11):817-822.

Publication type:

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. DESIGN: A doubleblind 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 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. CONCLUSION: 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.