Underlying Causes of Low Vitamin K Status in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT03493087|
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : April 18, 2019
Studies have shown that patients with chronic kidney disease in hemodialysis have a low vitamin K status which is believed to be related to an increased risk of atherosclerosis and increased bleeding tendency. The underlying causes of low vitamin K status in hemodialysis patients is unknown. Thus, the aim of this study is to investigate why hemodialysis patients have a low vitamin K status and how to improve it.
This study is composed of five trials. Four of them are based on possible hypotheses to the low vitamin K status. The hypotheses are:
- The daily intake of vitamin K is insufficient.
- Vitamin K is removed from the blood during dialysis.
- Absorption in the intestines is impaired.
- The analysis method (dephosphorylated-uncarboxylated MGP) is influenced by the patients' protein intake.
The purpose of the fifth trial is to investigate solutions to improve the vitamin K status of hemodialysis. One is to improve vitamin K status through diet with an increased focus on foods with high concentrations of vitamin K while considering phosphate, potassium and fluid restrictions. The second is to increase vitamin K status through a daily supplement of 360µg Menakinon-7.
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency, Chronic||Dietary Supplement: Menakinon 7 Dietary Supplement: Diet rich in vitamin K||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Underlying Causes of Low Vitamin K Status in Hemodialysis Patients|
|Actual Study Start Date :||February 22, 2018|
|Actual Primary Completion Date :||August 20, 2018|
|Actual Study Completion Date :||November 20, 2018|
Active Comparator: Menakinon-7
Menakinon-7 360 µg tablet by mouth, every day for 6 weeks
Dietary Supplement: Menakinon 7
Menakinon 7 - One tablet a day against vitamin K deficiency
Active Comparator: Diet with vitamin K
Diet rich in vitamin K for 6 weeks
Dietary Supplement: Diet rich in vitamin K
Diet with large content of vegetables and dairy products
- Δ-dp-uc-MGP (Sub-trial 5) [ Time Frame: 15 weeks ]Comparison of concentration of dp-ucMGP in blood samples through out the intervention
- dp-ucMGP status (Sub-trial 1) [ Time Frame: 1 day ]Concentration of dp-ucMGP in a blood sample collected before dialysis
- Vitamin K intake (Sub-trial 1) [ Time Frame: 1 month ]Intake of vitamin K is estimated from FFQ results
- dp-ucMGP concentration in dialysis water (Sub-trial 2) [ Time Frame: 1 day ]A sample of dialysis water is tested for dp-ucMGP
- Δ-concentration of dp-ucMGP (Sub-trial 2) [ Time Frame: 1 day ]Concentration of dp-ucMGP in a blood sample collected before dialysis is compared with the concentration in a blood sample collected after dialysis
- Δ-weight (Sub-trial 2) [ Time Frame: 1 day ]The patient's weight before and after dialysis is compared
- Concentration of D-xylose (Sub-trial 3) [ Time Frame: 1 day ]Concentration of D-xylose in the blood an hour after intake of 15g of D-xylose
- Fat in the diet (Sub-trial 3) [ Time Frame: 1 day ]The amount of fat in the diet is assessed from FFQ results
- Δ-dp-uc-MGP (Sub-trial 4) [ Time Frame: 14 day ]intervention with protein is compared with the concentration in a blood sample collected after the intervention
- Protein in the diet (Sub-trial 4) [ Time Frame: 14 days ]The amount of protein in the diet is assessed from FFQ results
- Calcification (Sub-trial 5) [ Time Frame: 15 weeks ]Blood samples are analyzed via calcification propensity score, T50
- Quality of life (Sub-trial 5) [ Time Frame: 15 weeks ]The results from mental and physical well being questionnaires are compared Based on SF-36 Danish version. Eight questions with scales ranges from 1-5 with 5 being the worse outcome. The questions are looked at individually and together.
- The patient's perception of the presence of bruises (Sub-trial 5) [ Time Frame: 15 weeks ]The patient assess the changes in bruising in a questionnaire.
- Δ-factor 2, 7,10 concentration (Sub-trial 5) [ Time Frame: 15 weeks ]Comparison of concentration of factor 2,7,10 in blood samples before and after both interventions
- Phosphate (Sub-trial 5) [ Time Frame: 15 weeks ]Changes in p-phosphate through out the intervention period
- Potassium (Sub-trial 5) [ Time Frame: 15 weeks ]Changes in p-potassium through out the intervention period
- Vitamin A (Sub-trial 5) [ Time Frame: 15 weeks ]Changes in p-vitamin A through out the supplement period
- Vitamin D (Sub-trial 5) [ Time Frame: 15 weeks ]Changes in p-vitamin D through out the supplement period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493087
|Herlev, Denmark, 2730|
|Study Director:||Jens Rikardt Andersen||University of Copenhagen|