Administration of Oral Vitamin K2 to Newborns

Ok well, today I'm not covering a new study, but over the last year, I've had numerous people ask about an article I wrote describing a protocol I put together for using vitamin K2 (as MK-7) in newborns (in lieu of the standard K1 injection).

I usually distribute this article when I'm delivering a seminar/presentation for vitamin K2 on behalf of Inno-Vite (for whom I developed the only liquid K on the Canadian market). However, for those who've never attended one of my presentations, or may have lost this article, I'm posting it here. This the latest version (from January 2011). Should there be a need to update this with newer relevant information, I'll post it to this blog.

If you prefer to obtain a pdf copy, please contact me using the link on this page and I'll be sure to email it to you.

...and a shameless plug for a product I'm proud to put my name behind...for this product I sourced the "cleanest" MK-7 (the only MK-7 raw material that doesn't contain dimethylpolysiloxane, and is also non-GMO, etc.) or use toxic preservatives like BHT in the vitamin D3 component (these are things you won't see on a label). It works great for newborns (based on feedback from many new parents and midwives, in addition to using it with my second son) and children, but also being used increasingly as a topical vitamin K serum for various skin conditions (mostly rosacea and wrinkles).

Update (July 17, 2012): Inno-Vite's newly launched Liquid K2 Extra Strength is the preferred and more appropriate version for use in newborns and infants, especially for the larger initial dose. Only 7 drops of the new Liquid K2 Extra Strength will provide more than the recommended 200 mcg for the initial dose (as opposed to 40 drops, or 2 mL, using the original version). Using the Liquid K2 Extra Strength will also be easier to administer daily since only 1 drop (30 mcg) will provide more than the recommended 25 mcg daily dose. However, since there is no D3 in the Extra Strength version, a separate D3 supplement should be considered.

Administration of Oral Vitamin K2 to Newborns

Lee Know, ND  |  www.KnowGuff.com  |  Originally published Aug 2010, updated January 2011

Since the launch of Inno-Vite’s Liquid K2 Drops, the product has become popular among parents who prefer to avoid the vitamin K injection at birth. This document is intended to give parents-to-be and their Midwives, Doulas, Naturopathic and Medical Doctors the information and guidance they need to make an informed choice on vitamin K.

First identified over 100 years ago, vitamin K deficiency bleeding (VKDB), formerly known as haemorrhagic disease of the newborn, presents as unexpected bleeding, often with gastrointestinal haemorrhage, bruising, and, in many cases, intracranial haemorrhage. Starting in the early 1960s, 0.5 – 1.0 mg of vitamin K (as K1, the only form of supplemental vitamin K available at the time) was administered intramuscularly (IM) to all newborns immediately after birth to prevent this problem.¹

In 1988, the Canadian Paediatric Society (CPS) indicated that 2.0 mg of vitamin K, when administered orally within six hours of birth, was an acceptable alternative.²

Interestingly, this was even before the suggestion that IM vitamin K shortly after birth increases the risk of childhood cancers^3,4 – and while several studies have refuted the link to solid tumours, a potential low risk of lymphoblastic leukemia cannot be ruled-out. In a review of the evidence available up to 2000, Ross & Davies evaluated ten case-controlled studies, seven of which found no relationship and three that found only a weak relationship between the use of IM vitamin K and leukemia.⁵

Although the American Academy of Pediatrics (AAP) has continued to advocate sole use of the IM route, other countries soon joined Canada in recommending the alternative oral administration of vitamin K. In contrast to the AAP, the CPS believes that, on the basis of new available information, recommendations should be modified. The 1988 CPS recommendations for oral vitamin K aimed to obtain the benefit of vitamin K for newborns without incurring pain associated with IM injections.²

While a review published in 1992 found that no serious complications were reported after 420,000 IM injections of vitamin K to newborns,⁶ the psychological effects of IM injections on newborn infants and their parents are unknown. Studies on circumcision have reported that pain experienced during the neonatal period may have long-term adverse effects.^7,8 However, since it’s clearly been demonstrated that vitamin K administration helps prevent VKDB, it’s important that it be given in the most effective manner.⁹ The newer CPS recommendations supported the oral administration of vitamin K (with a formulation designed for IM use) – a regimen reported to be effective, practical and economical.¹⁰

For expectant mothers who take medications that impair vitamin K metabolism, the mother should also take oral vitamin K to help prevent early VKDB (which occurs during the first 24 h of life).²

Classic VKDB (occurring in the first week of life) is rare when vitamin K is given to newborns.⁹

Late VKDB (occurring at 3 – 8 weeks of age) occurs almost exclusively among breastfed infants and has emerged as a more serious concern in numerous countries.^11-16 In these countries, as the oral administration of vitamin K (rather than IM) became available as an acceptable alternative, the incidence of late VKDB increased at the same time.

Results of other studies shed light on why this trend was seen. At five days of age, there appeared to be no difference whether vitamin K was administered orally or IM.¹⁸ However, at age four to six weeks, biochemical signs of vitamin K deficiency were observed in up to 19% of infants given 2.0 mg of vitamin K orally at birth in comparison to only 5.5% of those given 1.0 mg IM.¹⁹

An epidemiological study from Germany⁶ showed a failure rate (occurrence of late VKDB) after IM administration of 0.25 (per 100,000 infants), compared with a rate of 1.4 after oral administration. In other countries in which oral administration is the primary form of vitamin K prophylaxis, the incidence of late VKDB varied – 1.5 (Britain), 6.0 (Sweden) and 6.4 (Switzerland) per 100,000 infants.^6,16 However, it was suggested that some of these infants could have had underlying disorders (e.g. liver disease) that affected vitamin K metabolism.²⁰

The lower risk of VKDB with IM administration over single-dose oral administration^3,11-13 is likely due to the storage of vitamin K in the muscle tissue and slow-release following an IM injection.²⁷ To better mimic this storage and slow-release, repeated oral doses of vitamin K have been suggested over a single oral dose at birth.^13,17

Repeated oral doses should be reserved for infants whose parents refuse IM injection of vitamin K following birth. If parents choose oral dosing, repeated doses are advised over a single dose at birth, and small daily doses may be preferred over larger weekly doses. An epidemiological study published in 1997 found that a daily oral dose of 25 mcg after an initial dose of 1 mg vitamin K may be just as effective as IM injections.²¹ However, this low daily dose failed to prevent VKDB in apparently healthy infants with unrecognized liver disease.²⁶

It is important to note that even IM administration of vitamin K does not provide complete protection from VKDB, especially in breastfed infants whose oral intake of vitamin K is low. Since the risks of late VKDB are greatest in breastfed babies, it has been suggested that there may be benefit to giving lactating mothers vitamin K as well.^22,23

Some also suggest administering probiotics (beneficial bacteria in the digestive tract, some of which produce vitamin K2 endogenously) to newborns, especially if the infant was delivered by c-section, where the newborn is not colonized by the beneficial bacteria present in the mother’s birth canal.

Recommendations for Oral Vitamin K2 (as MK-7)

Note that all references to vitamin K above used K1, which has low bioavailability and short biological half-life. Low bioavailability is likely the reason for such high oral doses (e.g. 2 mg) and the short half-life is likely the reason why there is a higher rate of failure for late VKDB with oral dosing, especially when administered in a single dose upon birth, or dosed only once a week.

However, since the 1960s, the drug and nutrition industries have a few more forms of vitamin K available. Inno-Vite’s Liquid K2 Drops uses the MK-7 form of vitamin K2. It has excellent bioavailability, and a very long biological half-life in comparison to K1.²⁴

For this reason, my personal opinion is that a smaller initial dose of 200 mcg oral dose at birth, followed by a daily dose of 25 mcg (continuing at least until 8 – 12 weeks of age) would be sufficient. If the infant vomits or regurgitates within 1 hour of an oral dose, the dose should be repeated.

 
A direct comparison of MK-7 to K1 suggested 25 mcg of MK-7 was approximately equivalent to 62.5 mcg of K1.²⁴ Considering this, some may think my recommendations are a bit on the high end. However, as a licensed Naturopathic Doctor, I’m required to err on the side of safety, and in this case, the goal is to minimize the risk of VKDB. Please realize that this is my own opinion and not definitive medical protocol or advice. Also note, just as with oral K1, infants with unrecognised liver disease would not be fully protected.

Breastfeeding mothers should also take 120 mcg daily, some of which will be transferred to the infant while nursing (vitamin K is also essential for optimal bone health and cardiovascular health).

Besides vitamin K to reduce the risk of VKDB, a healthy infant being nursed by a healthy mother does not need any additional vitamins or nutritional supplements, with the exception of vitamin D.²⁵ While breast milk does contain small amounts of vitamin D, it is primarily produced by the body when the skin is exposed to sunlight. However, sun exposure increases the risk of skin damage, so parents are advised to minimize exposure. The AAP recommends that all breastfed babies begin receiving vitamin D supplements during the first 2 months and continuing until the infant consumes enough vitamin D-fortified food/beverages. Thus, the Liquid K2 Drops also contains a small amount of vitamin D3.

Lastly, some evidence suggests vitamin K supplementation may not be needed in formula-fed infants since formula will contain sufficient amounts (although vitamin D supplementation may still be necessary²⁵). There is even some question as to the necessity of IM vitamin K in newborns whose mother has already decided, either due to a medical condition or personal choice prior to birth, that breastfeeding is not an option.

Please review the pros and cons of oral vs. IM vitamin K with your healthcare provider, who can suggest the best possible course of action depending on you and your newborn’s unique situation and desires.

Clinical Pearls:

·         Use a graduated dropper or syringe for the initial dose of 200 mcg. 40 drops (or 2 mL) is difficult to administer to a newborn using the enclosed dropper. Drawing up 2 mL of the solution into the graduated dropper or syringe, and administering orally is the best solution (if using the syringe, be sure to remove the needle before drawing the medicine and administering to the newborn).

·         An initial dose of 2 mL will be a relatively large volume for a newborn. Try administering the 2 mL dose over the course of the first 6 hours in divided doses.

·         One of the main drawbacks to oral vitamin K is compliance. Parents may forget to administer or stop administering the vitamin K earlier than suggested. If choosing this the oral route, parents must be committed to following through with the recommendations to the end.

·         Most cases of severe VKDB are preceded by “warning bleeds” and it is important for practitioners and parents to be aware that spontaneous bleeding in the first six months of life may be caused by VKDB. Examples of “warning bleeds” include bleeding from the nose or umbilicus, spontaneous bruising, and black stools (not including meconium). Parents who have opted for no vitamin K prophylaxis should particularly be made aware of these signs.

DISCLAIMER: The information contained in this article is for educational purposes only and not to be construed as medical advice. It is not meant to diagnose, treat, or in any way replace qualified medical supervision. For any medical conditions, consult with your health care provider before using any products. Background information adapted from the Canadian Paediatric Society’s position statement titled “Routine administration of vitamin K to newborns.”

References

1.        Committee on Nutrition, American Academy of Pediatrics. Vitamin K compounds and the water-soluble analogues: Use in therapy and prophylaxis in pediatrics. Pediatrics 1961;28:501-7.

2.        Fetus and Newborn Committee, Canadian Paediatric Society. The use of vitamin K in the perinatal period. Can Med Assoc J 1988;139:127-30.

3.        Golding J, Paterson M, Kinlen LJ. Factors associated with childhood cancer in a national cohort study. Br J Cancer 1990;62:304-8.

4.        Golding J, Greenwood R, Birmingham K, et al. Childhood cancer, intramuscular vitamin K and pethidine given during labour. BMJ 1992;305:341-6.

5.        Ross JA, Davies SM. Vitamin K prophylaxis and childhood cancer. Med Pediatr Oncol 2000;34:434-7.

6.        von Kries R. Vitamin K prophylaxis – A useful public health measure? Paediatr Perinat Epidemiol 1992;6:7-13.

7.        Taddio A, Goldbach M, Ipp M, et al. Effect of neonatal circumcision on pain responses during vaccination in boys. Lancet 1995;345:291-2.

8.        Taddio A, Katz J, Ilersich AL, Koren G. Effect of neonatal circumcision on pain response during subsequent routine vaccination. Lancet 1997;349:599-603.

9.        Lane PA, Hathaway WE. Medical progress: Vitamin K in infancy. J Pediatr 1985;106:351-9.

10.     Allen AC. The use of vitamin K in the perinatal period. Can Med Assoc J 1989;140:13-4.

11.     von Kries R, Göbel U. Oral vitamin K prophylaxis and late haemorrhagic disease of the newborn. Lancet 1994;343:352. (Lett)

12.     McNinch A, Tripp JH. Haemorrhagic disease of the newborn in the British Isles: two-year prospective study. BMJ 1991;303:1105-9.

13.     Ekelund H. Late hemorrhagic disease in Sweden 1987-89. Acta Paediatr Scand 1991;80:966-8.

14.     Enochksson E, Jonsson B. Hemorrhagic disease of the newborn. Several cases of late onset despite oral vitamin K prophylaxis. Lakartidningen 1990;87:1944-5.

15.     Loughan PM, McDougall PN. The efficacy of oral vitamin K₁: Implications for future prophylaxis to prevent haemorrhagic disease of the newborn. J Paediatr Child Health 1993;29:171-6.

16.     Loughnan PM, McDougall PN. Epidemiology of late onset haemorrhagic disease: A pooled data analysis. J Paediatr Child Health 1993;29:177-81.

17.     National Health and Medical Research Council, The Australian College of Paediatrics and the Royal Australian College of Obstetricians and Gynaecologists. Joint statement and interim recommendations on vitamin K prophylaxis for hemorrhagic disease in infancy. J Paediatr Child Health 1993;29:182.

18.     Jrrgensen FS, Felding P, Vinther S, Andersen GE. Vitamin K to neonates peroral versus intramuscular administration. Acta Paediatr Scand 1991;80:304-7.

19.     Hathaway WE, Isarangkura PB, Mahasandana C, et al. Comparison of oral and parenteral vitamin K prophylaxis for prevention of late hemorrhagic disease of the newborn. J Pediatr 1991;119:461-4.

20.     von Kries R, Shearer MJ, Göbel U. Vitamin K in infancy. Eur J Pediatr 1988;147:106-12.

21.     Cornelissen M, von Kries R, Loughnan P, Schubiger G. Prevention of vitamin K deficiency bleeding: Efficacy of different multiple oral dose schedules of vitamin K. Eur J Pediatr 1997;156:126-30.

22.     Nishiguchi T, Saga K, Sumimoto K, Okada K, Terao T. Vitamin K prophylaxis to prevent neonatal vitamin K deficient intracranial hemorrhage in the Shizuoka prefecture. Br J Obstet Gynaecol 1996;103:1078-84.

23.     Greer FR, Marshall SP, Foley AL, Suttie JW. Improving the vitamin K status of breastfeeding infants with maternal vitamin K supplements. Pediatrics 1997;99:88-92.

24.     Schurgers LJ, Teunissen KJ, Hamulyák K, Knapen MH, Vik H, Vermeer C. Vitamin K-containing dietary supplements: comparison of synthetic vitamin K1 and natto-derived menaquinone-7. Blood. 2007 Apr 15;109(8):3279-83.

25.     Gallo S, Jean-Philippe S, Rodd C, Weiler HA. Vitamin D supplementation of Canadian infants: practices of Montreal mothers. Appl Physiol Nutr Metab. 2010 Jun;35(3):303-9.

26.     van Hasselt PM, de Koning TJ, Kvist N, de Vries E, Lundin CR, Berger R, Kimpen JL, Houwen RH, Jorgensen MH, Verkade HJ; Netherlands Study Group for Biliary Atresia Registry. Prevention of vitamin K deficiency bleeding in breastfed infants: lessons from the Dutch and Danish biliary atresia registries. Pediatrics. 2008 Apr;121(4):e857-63.

27.     Loughnan PM, McDougall PN. Does intramuscular vitamin K1 act as an unintended depot preparation? J Paediatr Child Health 1996;32(3):251-4.

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