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Vitamin K Deficiency clinical trials

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NCT ID: NCT05943457 Not yet recruiting - Arterial Stiffness Clinical Trials

Vitamin K2 Supplementation in Adult Episodic Migraine

ViKEM
Start date: September 2023
Phase: N/A
Study type: Interventional

Migraine is a debilitating illness and a major cause of disability in the world. It is highly prevalent, especially among women. Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. Several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. Vitamin K2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix Gla protein (MGP). Supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. Therefore, vitamin K2 supplementation could serve a potential role in migraine patients. The purpose of the study is to test the effect of vitamin K2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. The population will be recruited from the neurology clinic at LAU Medical Center-Rizk Hospital and will constitute of adult patients. They will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months. Laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.

NCT ID: NCT05713045 Completed - Clinical trials for Late Vitamin K Deficiency-related Bleeding

Late Vitamin K Deficiency-related Bleeding in Neonates (VKLB): Comparison of Different Strategies to Prophylaxis

VKLB
Start date: March 27, 2020
Phase:
Study type: Observational

The goal of this multicentric observational study was to compare four vitamin K dosing regimens in exclusively breastfed healthy term newborns. The main questions it aims to answer were: - comparing protein induced by vitamin K absence (PIVKA) levels in the different prophylaxis protocols at 48 hours, 1 month and 4 months - to investigate the compliance and safety of oral vitamin K 1 administration Participants received vitamin K prophilaxis according to birth Hospital regimen. A blood sample was taken at 48 hours, 1 month and 3 months of life. Plasmatic PIVKA-II concentretion was be dosed Researchers compared four groups of Vitamin K dosing regimens: 1. an intramuscolar injection of 1 mg vitamin K at birth 2. an intramuscolar injection of 1 mg vitamin K at birth followed by 50 μg/die orally from the second to the fourteenth week of life. 3. an intramuscolar injection of 1 mg vitamin K at birth followed by 150 μg/die orally from the second to the fourteenth week of life. 4. an oral dose of 2 mg vitamin K at birth, followed by a second dose at 4 weeks, and a third dose at 12 weeks to see if there is PIVKA-II plasmatic concentration differences.

NCT ID: NCT05360342 Completed - Clinical trials for Vitamin K Deficiency

Incorporation of Vitamin K Into Uremic Lipoproteins

Start date: March 31, 2020
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.

NCT ID: NCT04900610 Not yet recruiting - Clinical trials for End Stage Renal Disease

The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis

VIKIPEDIA
Start date: September 2021
Phase: N/A
Study type: Interventional

VIKIPEDIA is a multi-centre, placebo-controlled, randomized, open-label intervention clinical trial on Peritoneal Dialysis (PD) patients. At baseline the investigators will recruit End-Stage Renal Disease patients undergoing PD and randomize them to either daily per os supplementation of 1mg menaquinone-7 or placebo for 1.5 year. The investigators will study the effect of vitamin K2 supplementation (through normalization of dp-ucMGP) on arterial stifness and the occurence of cardiovascular events. The investigators will also cosider as secondary endpoints, mortality, central aortic blood pressure and indices of 24h-ambulatory blood pressure.

NCT ID: NCT04517461 Completed - Clinical trials for Head and Neck Cancer

Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery

MVL-COAG
Start date: September 15, 2020
Phase:
Study type: Observational

For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap. Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery. The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.

NCT ID: NCT04188080 Completed - Clinical trials for Vitamin K Deficiency

Estimation of a Maintaining Daily Jarlsberg Cheese-dose

Start date: January 16, 2020
Phase: N/A
Study type: Interventional

The study objective is to estimate a maintaining daily dose of Jarlsberg cheese in healthy pre-menopausal women obtaining an increase in the osteocalcin level of at least 10% after 6 weeks on maximum efficacy dose (MED) of Jarlsberg cheese. 1.4: Population and sampling The study population consists of Healthy Voluntary (HV) women between 20 years and pre-menopausal age. The study will be performed as a one-dimensional, within-patient, 3-level Response Surface Pathway (RSP) designed trial with individually adjustment of the dose. Each design period will be 3 weeks. Only HVs obtaining an increase in the osteocalcin level ≥ 10% from baseline after 6 weeks on the MED of 57g Jarlsberg cheese daily will be offered to participate in this de-escalation study.

NCT ID: NCT03871322 Recruiting - Fracture Healing Clinical Trials

The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

a prospective, three- month, randomized, double-blind, placebo-controlled, intervention trial (RDBPC), investigating the effect of vitamin K2 (menaquinone-7) and vitamin D3 on the healing process of low-energy bone fractures in children and adolescents

NCT ID: NCT03782025 Completed - Clinical trials for Vitamin K Deficiency

Effect of Vitamin K in Critically Ill Patients

VITAKOAG
Start date: February 13, 2019
Phase:
Study type: Observational

Critically ill patients with spontaneously prolonged pro-thrombin time, where administration of intravenous administration of phytomenadione (vitamin K) has been ordered by the treating physician will be identified. After signed informed consent baseline samples will be collected. Phytomenadione will be given and 24 hours after administration new blood samples will be collected. Several different advanced coagulation and vitamin K-assays will be performed before and 24 hours after vitamin K administration.

NCT ID: NCT03311321 Recruiting - Clinical trials for Cardiovascular Diseases

Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients

Start date: September 13, 2017
Phase: N/A
Study type: Interventional

The life span of adults with end-stage renal disease is reduced, and cardiovascular disease (CVD) accounts for approximately half the deaths among those undergoing hemodialysis (HD). Vascular calcification is a key process in the development of atherosclerotic and arteriosclerotic CVD, and contributes significantly to the greater mortality rates and CVD events in HD patients. Recently, there has been growing interest in the vitamin K-dependent matrix Gla protein (MGP) and its role in inhibiting vascular calcification. Animal studies have revealed that the vitamin K-dependent protein MGP may reduce the progression of vascular calcification, possibly by means of improving vascular function. The relationship between MGP and vitamin K lies in the fact that inactive matrix Gla protein requires vitamin K to carboxylate it for its activation. Currently, data in HD patients are scant and equivocal on the effects of vitamin K supplementation on CVD risk outcomes. Therefore, the purpose of this 8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether daily vitamin K supplementation can favorably alter measurements of endothelial function and arterial stiffness in HD patients.

NCT ID: NCT02870829 Completed - Clinical trials for Vascular Calcification

Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

TReVasc-HDK
Start date: July 2016
Phase: Phase 2
Study type: Interventional

The proposed study will seek to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients in Asian population. It will also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of vascular calcification in this group of patients. This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute difference in coronary artery calcium (CAC) score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular events (MACE) over the same period.