Clinical trial NCT06765265: Impact of Atorvastatin Versus Rosuvastatin on 25 Hydroxy Vitamin D Levels in Patients With Acute Coronary Syndrome
Official title: Impact of Atorvastatin Versus Rosuvastatin on 25 Hydroxy Vitamin D Levels in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndromes
Keywords: atorvastatin
rosuvastatin
Vitamin D
Triglyceride
Lipid Profile
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: there will be 2 groups of patients with acute coronary syndrome. The patients will receive one of the 2 study drugs and impact on raising Vitamin D level will be seen after 6 months

Detailed description: this randomized clinical trial will include 152 patients of acute coronary syndrome with normal Vitamin D levels. they will be randomized to receive either Atorvastatin or Rosuvastatin. After 6 months of therapy, the impact on Vitamin D levels will be checked

Eligibility criteria: Inclusion Criteria:

Acute Coronary Syndrome

25 OH-Vitamin D levels between 30-70ng/ml

Exclusion Criteria:

Hypercalcemia

hypocalcemia

pregnancy

lactation

hypersensitivity to statins

hypothyroidism

Deranged LFTs \& RFTs

Use of following within last 3 months (Vitamin D Supplements, lipid lowering drugs, anti-obesity drugs, corticosteroids)

Primary outcomes:
measure: Serum Vitamin D
timeFrame: 24 weeks
Secondary outcomes:
measure: Lipid Profile
timeFrame: 4 weeks & 24 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Uzma Malik
role: STUDY_CHAIR
affiliation: King Edward Medical University
name: Ali Hussnain
role: PRINCIPAL_INVESTIGATOR
References:
citation: Althanoon Z, Faisal IM, Ahmad AA, Merkhan MM, Merkhan MM. Pharmacological aspects of statins are relevant to their structural and physicochemical properties. Systematic Reviews in Pharmacy. 2020 Jul 1;11(7):167-71
citation: Levinson SS. Non-High-Density Lipoprotein Cholesterol and Guidelines for Cholesterol Lowering in Recent History. Lab Med. 2020 Jan 2;51(1):14-23. doi: 10.1093/labmed/lmz032.
citation: Sathyapalan T, Shepherd J, Arnett C, Coady AM, Kilpatrick ES, Atkin SL. Atorvastatin increases 25-hydroxy vitamin D concentrations in patients with polycystic ovary syndrome. Clin Chem. 2010 Nov;56(11):1696-700. doi: 10.1373/clinchem.2010.144014. Epub 2010 Sep 3.
citation: Thabit A, Alhifany A, Alsheikh R, Namnqani S, Al-Mohammadi A, Elmorsy S, Qari M, Ardawi M. Effect of simvastatin and atorvastatin on serum vitamin d and bone mineral density in hypercholesterolemic patients: a cross-sectional study. J Osteoporos. 2014;2014:468397. doi: 10.1155/2014/468397. Epub 2014 Aug 13.
citation: Anagnostis P, Adamidou F, Slavakis A, Polyzos SA, Selalmatzidou D, Panagiotou A, Athyros VG, Karagiannis A, Kita M. Comparative Effect of Atorvastatin and Rosuvastatin on 25-hydroxy-Vitamin D Levels in Non-diabetic Patients with Dyslipidaemia: A Prospective Randomized Open-label Pilot Study. Open Cardiovasc Med J. 2014 Jul 11;8:55-60. doi: 10.2174/1874192401408010055. eCollection 2014.
citation: Demir CC, Mousa U, Anil C. Effects of atorvastatin and rosuvastatin therapy on serum 25-hydroxyvitamin D levels: A comparative study 13th European Congress of Endocrinology. Endocr Abstr. 2011;26(1):548.
citation: Bauddh NK, Ranga GS. A study of the effect of rosuvastatin on vitamin D levels in patients with hypertension, diabetes mellitus, and coronary artery disease. Int J Health Sci Res. 2016; 6(7):42-6
citation: Patwardhan VG, Mughal ZM, Padidela R, Chiplonkar SA, Khadilkar VV, Khadilkar AV. To study impact of treatment with Rosuvastatin versus Atorvastatin on 25 hydroxy Vitamin D concentrations among adult Indian men- a randomized control trial. Indian J Pharmacol. 2020 Sep-Oct;52(5):365-371. doi: 10.4103/ijp.IJP_93_18.
citation: Jorge AJ, Cordeiro JR, Rosa ML, Bianchi DB. Vitamin D deficiency and cardiovascular diseases. Int J Cardiovas Sci. 2018;31(1):422-32
citation: Sahebkar A, Reiner Z, Simental-Mendia LE, Ferretti G, Della Corte C, Nobili V. Impact of Statin Therapy on Plasma Vitamin D Levels: A Systematic Review and Meta-Analysis. Curr Pharm Des. 2017;23(6):861-869. doi: 10.2174/1381612822666161006150542.
citation: Radhakrishnan A, Ruckmani A, Abishek M, Govindaraju S. Statin therapy and Vitamin D. Int J Basic Clin Pharmacol. 2015;4:1113-7.
citation: Bhattacharyya S, Bhattacharyya K, Maitra A. Possible mechanisms of interaction between statins and vitamin D. QJM. 2012 May;105(5):487-91. doi: 10.1093/qjmed/hcs001. Epub 2012 Feb 9. No abstract available.
citation: Scragg R. The Vitamin D Assessment (ViDA) study - Design and main findings. J Steroid Biochem Mol Biol. 2020 Apr;198:105562. doi: 10.1016/j.jsbmb.2019.105562. Epub 2019 Dec 3.
citation: Verdoia M, Pergolini P, Rolla R, Nardin M, Schaffer A, Barbieri L, Daffara V, Marino P, Bellomo G, Suryapranata H, De Luca G; Novara Atherosclerosis Study Group (NAS). Impact of high-dose statins on vitamin D levels and platelet function in patients with coronary artery disease. Thromb Res. 2017 Feb;150:90-95. doi: 10.1016/j.thromres.2016.12.019. Epub 2016 Dec 28.