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The investigators planned to research the effect of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.
Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Lipid abnormalities are common in the general population, and are regarded as a modifiable risk factor for cardiovascular disease. Recently low vitamin D status has been shown to be associated with increased risk of developing hyperlipidemia. Statins are normally the first-line therapy for hypercholesterolemia. It is also reported that vitamin D can improve serum lipid levels. However, its effects on hypercholesterolemia patients remain unclear. The investigators planned to determine the efficacy of combination therapy with statins and vitamin D in a cohort of hypercholesterolemia patients. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in hypercholesterolemia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D supplementation group | Experimental | drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months. |
|
| Control group | Placebo Comparator | drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 tablets | Drug | 2000 IU vitamin D3 tablets were taken daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| a change in serum total cholesterol level | The primary end point was a change in serum total cholesterol level after 6 months of vitamin D supplementation. | after 6 months of vitamin D supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| a change in serum triglycerides level | The change in serum triglycerides level was measured after 6 months of vitamin D supplementation. | after 6 months of vitamin D supplementation |
| differences in the incidences of treatment-emergent adverse events |
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Inclusion Criteria:
The main inclusion criteria were for hypercholesterolemia patients with the treatment of statins.
Exclusion Criteria:
The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders. Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Shi, M.D. | Contact | +8610-66876231 | ggyyong@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Tang Wang, M.D. | PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19091317 | Background | Kendrick J, Targher G, Smits G, Chonchol M. 25-Hydroxyvitamin D deficiency is independently associated with cardiovascular disease in the Third National Health and Nutrition Examination Survey. Atherosclerosis. 2009 Jul;205(1):255-60. doi: 10.1016/j.atherosclerosis.2008.10.033. Epub 2008 Nov 11. | |
| 17624643 | Background |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| placebo tablets | Drug | 2000 IU placebo tablets were taken daily for 6 months |
|
Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation
| after 6 months of vitamin D supplementation |
| Botella-Carretero JI, Alvarez-Blasco F, Villafruela JJ, Balsa JA, Vazquez C, Escobar-Morreale HF. Vitamin D deficiency is associated with the metabolic syndrome in morbid obesity. Clin Nutr. 2007 Oct;26(5):573-80. doi: 10.1016/j.clnu.2007.05.009. Epub 2007 Jul 10. |
| 22986625 | Background | Skaaby T, Husemoen LL, Pisinger C, Jorgensen T, Thuesen BH, Fenger M, Linneberg A. Vitamin D status and changes in cardiovascular risk factors: a prospective study of a general population. Cardiology. 2012;123(1):62-70. doi: 10.1159/000341277. Epub 2012 Sep 12. |
| 22947589 | Background | Ponda MP, Dowd K, Finkielstein D, Holt PR, Breslow JL. The short-term effects of vitamin D repletion on cholesterol: a randomized, placebo-controlled trial. Arterioscler Thromb Vasc Biol. 2012 Oct;32(10):2510-5. doi: 10.1161/ATVBAHA.112.254110. Epub 2012 Sep 4. |
| 18754003 | Result | Schwartz JB. Effects of vitamin D supplementation in atorvastatin-treated patients: a new drug interaction with an unexpected consequence. Clin Pharmacol Ther. 2009 Feb;85(2):198-203. doi: 10.1038/clpt.2008.165. Epub 2008 Aug 27. |
| 24844869 | Derived | Qin XF, Zhao LS, Chen WR, Yin DW, Wang H. Effects of vitamin D on plasma lipid profiles in statin-treated patients with hypercholesterolemia: A randomized placebo-controlled trial. Clin Nutr. 2015 Apr;34(2):201-6. doi: 10.1016/j.clnu.2014.04.017. Epub 2014 May 2. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |