Vitamin K1 (Phytonadione) - Summary

VITAMIN K1 SUMMARY

VITAMIN K1
INJECTION
Phytonadione
Injectable Emulsion, USP

Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol.

Vitamin K₁ Injection (Phytonadione Injectable Emulsion, USP) is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.

Vitamin K₁ Injection is indicated in:

• anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;

• prophylaxis and therapy of hemorrhagic disease of the newborn;

• hypoprothrombinemia due to antibacterial therapy;

• hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;

• other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

NEWS HIGHLIGHTS

Published Studies Related to Vitamin K1 (Phytonadione)

Vitamin K supplementation and progression of coronary artery calcium in older men and women. [2009.06]
BACKGROUND: Coronary artery calcification (CAC) is an independent predictor of cardiovascular disease. A preventive role for vitamin K in CAC progression has been proposed on the basis of the properties of matrix Gla protein (MGP) as a vitamin K-dependent calcification inhibitor. OBJECTIVE: The objective was to determine the effect of phylloquinone (vitamin K1) supplementation on CAC progression in older men and women... CONCLUSIONS: Phylloquinone supplementation slows the progression of CAC in healthy older adults with preexisting CAC, independent of its effect on total MGP concentrations. Because our data are hypothesis-generating, further studies are warranted to clarify this mechanism. This trial was registered at clinicaltrials.gov as NCT00183001.

Association of sequence variations in vitamin K epoxide reductase and gamma-glutamyl carboxylase genes with biochemical measures of vitamin K status. [2009.04]
Genetic factors, specifically the VKORC1 and GGCX genes, have been shown to contribute to the interindividual variability in response to the vitamin K-antagonist, warfarin, which influences the dose required to achieve the desired anticoagulation response...

Oral vitamin K versus placebo to correct excessive anticoagulation in patients receiving warfarin: a randomized trial. [2009.03.03]
BACKGROUND: Low-dose oral vitamin K decreases the international normalized ratio (INR) in overanticoagulated patients who receive warfarin therapy. Its effects on bleeding events are uncertain. OBJECTIVE: To see whether low-dose oral vitamin K reduces bleeding events over 90 days in patients with warfarin-associated coagulopathy... CONCLUSION: Low-dose oral vitamin K did not reduce bleeding in warfarin recipients with INRs of 4.5 to 10.0. Funding: Canadian Institutes of Health Research and Italian Ministry of Universities and Research.

Effect of low dose vitamin K2 (MK-4) supplementation on bio-indices in postmenopausal Japanese women. [2009.02]
It has been reported that treatment with a pharmacological dose (45 mg/d) of menaquinone-4 (MK-4) prevents bone loss in postmenopausal women. However, it is not known whether supplementation with low dose MK-4 has beneficial effects on bone metabolism in healthy women... Thus, the additional intake of MK-4 might be beneficial in the maintenance of bone health in postmenopausal Japanese women.

Vitamin K in hand osteoarthritis: results from a randomised clinical trial. [2008.11]
OBJECTIVES: Vitamin K has bone and cartilage effects, and previously shown to be associated with radiographic osteoarthritis. We evaluated vitamin K's effect on hand osteoarthritis in a randomised controlled trial... CONCLUSIONS: There was no overall effect of vitamin K on radiographic hand osteoarthritis. SUBJECTS: that were insufficient in vitamin K at baseline who attained sufficient concentrations at follow-up may have had a benefit in joint space narrowing. A clinical trial in those who are vitamin K insufficient may be warranted. TRIAL REGISTRATION NUMBER: NCT00183001.

more studies >>

Clinical Trials Related to Vitamin K1 (Phytonadione)

Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma [Recruiting]
Gamma tocopherol (gt) is a naturally occurring form of vitamin E that is found in many foods, and is also commercially available as a vitamin supplement. The purpose of this Phase 1 research study is to see if two doses of gt, 600mg and 1200mg, are safe (do not cause gastrointestinal distress or other problems), and can cause changes in your blood levels of gt and other antioxidants. This study will also examine if there is a difference in response between asthmatic and non-asthmatic adults when taking the same dose of gt. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation.

Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? [Completed]
Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage. Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test called Shilling’s test has been used for evaluation of the vitamin B12 absorption. However, the Schilling’s test is no longer easy accessible because of increasing difficulties to obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for Schilling’s test II (absorption of vitamin B12 attached to intrinsic factor) is no longer available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12 has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin B12 in patients with evident vitamin B12 deficiency.

Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development [Completed]
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life.

The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

Dose-Finding Study for Vitamin K2 in Human Volunteers [Completed]
Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, menaquinone-7 (MK-7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains which dosage of MK-7 leads to optimal carboxylation levels of these proteins.

The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK-7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.

Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy [Active, not recruiting]
Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.

more trials >>