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The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.
Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries [3, 4]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K2 group | Active Comparator | 15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months. |
|
| Cholecalciferol group | Active Comparator | 15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months. |
|
| Vitamin K2 and Cholecalciferol group | Active Comparator | 15 patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D to daily in addition to the standard therapy for 4 months. |
|
| Control group | No Intervention | 15 patients will take the standard therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 | Drug | Patients will take 90 ug of vitamin K2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncarboxylated MGP | Measuring serum level of Uncarboxylated MGP as a marker for calcification | 4 months |
| Uncarboxylated osteocalcin | Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification | 4 months |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radwa Maher El Borolossy | Recruiting | Cairo | 0000 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34845313 | Derived | El Borolossy R, El-Farsy MS. The impact of vitamin K2 and native vitamin D supplementation on vascular calcification in pediatric patients on regular hemodialysis. A randomized controlled trial. Eur J Clin Nutr. 2022 Jun;76(6):848-854. doi: 10.1038/s41430-021-01050-w. Epub 2021 Nov 29. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| D002762 | Cholecalciferol |
| D002112 | Calcifediol |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Cholecalciferol (inactive vitamin D) | Drug | Patients will take 10 ug of vitamin inactive vitamin D |
|
|
| Vitamin K2 and Cholecalciferol | Drug | Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D |
|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D006887 | Hydroxycholecalciferols |