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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018125-70 | EudraCT Number |
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In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity, N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Active Comparator | The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3; producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks |
|
| Placebo | Placebo Comparator | Oily drops as placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3, producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour systolic ambulatory blood pressure | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour diastolic ambulatory blood pressure | 8 weeks | |
| N-terminal-pro-brain natriuretic peptide (NT-pro-BNP) | 8 weeks | |
| corrected QT interval (Bazett formula) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Pilz, MD, PhD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34629245 | Derived | Grubler MR, Zittermann A, Verheyen ND, Trummer C, Theiler-Schwetz V, Keppel MH, Malle O, Richtig G, Gangler S, Bischoff-Ferrari H, Scharnagl H, Meinitzer A, Marz W, Tomaschitz A, Pilz S. Randomized trial of vitamin D versus placebo supplementation on markers of systemic inflammation in hypertensive patients. Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3202-3209. doi: 10.1016/j.numecd.2021.07.028. Epub 2021 Aug 18. | |
| 28027911 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency 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 | Dietary Supplement |
|
| 8 weeks |
| Renin | Plasma renin concentration | 8 weeks |
| Aldosterone | Plasma aldosterone concentration | 8 weeks |
| 24-hour urinary albumin excretion | 8 weeks |
| HOMA-IR | HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance) | 8 weeks |
| Triglycerides | 8 weeks |
| HDL-cholesterol | 8 weeks |
| Pulse wave velocity | 8 weeks |
| Derived |
| Grubler MR, Gaksch M, Kienreich K, Verheyen ND, Schmid J, Mullner C, Richtig G, Scharnagl H, Trummer C, Schwetz V, Meinitzer A, Pieske B, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D3 on asymmetric- and symmetric dimethylarginine in arterial hypertension. J Steroid Biochem Mol Biol. 2018 Jan;175:157-163. doi: 10.1016/j.jsbmb.2016.12.014. Epub 2016 Dec 24. |
| 27098193 | Derived | Grubler MR, Gaksch M, Kienreich K, Verheyen N, Schmid J, O Hartaigh BW, Richtig G, Scharnagl H, Meinitzer A, Pieske B, Fahrleitner-Pammer A, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D Supplementation on Plasma Aldosterone and Renin-A Randomized Placebo-Controlled Trial. J Clin Hypertens (Greenwich). 2016 Jul;18(7):608-13. doi: 10.1111/jch.12825. Epub 2016 Apr 21. |
| 27006655 | Derived | Ernst JB, Tomaschitz A, Grubler MR, Gaksch M, Kienreich K, Verheyen N, Marz W, Pilz S, Zittermann A. Vitamin D Supplementation and Hemoglobin Levels in Hypertensive Patients: A Randomized Controlled Trial. Int J Endocrinol. 2016;2016:6836402. doi: 10.1155/2016/6836402. Epub 2016 Feb 23. |
| 25801871 | Derived | Pilz S, Gaksch M, Kienreich K, Grubler M, Verheyen N, Fahrleitner-Pammer A, Treiber G, Drechsler C, O Hartaigh B, Obermayer-Pietsch B, Schwetz V, Aberer F, Mader J, Scharnagl H, Meinitzer A, Lerchbaum E, Dekker JM, Zittermann A, Marz W, Tomaschitz A. Effects of vitamin D on blood pressure and cardiovascular risk factors: a randomized controlled trial. Hypertension. 2015 Jun;65(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.115.05319. Epub 2015 Mar 23. |
| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |