Study to Assess the Effect of Zinc in Atorvastatin Treated Hyperlipidemic Patients
Primary Purpose
Hyperlipidemias
Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Zinc sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias focused on measuring Atorvastatin, Zinc, Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Age: 18 to 75 years
- Sex: both male and female
- Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension.
- A person can develop hyperlipidemia if they have one or a combination of the following: Diagnostic criteria for dyslipidemic patients (NCEP ATP III guideline) Total Cholesterol > 240 mg/dl LDL-C > 100 mg/dl Triglyceride > 150 mg/dl HDL-C < 40 mg/dl
Exclusion Criteria:
- Patients with renal impairment.
- Patient with history of active liver disease (e.g. jaundice, hepatitis, cirrhosis)
- Patients having hypersensitivity to drugs.
- Patients with any systemic diseases or having serious infections or terminal illness (e.g.-tuberculosis, HIV, malignant tumor)
- Pregnant woman
- lactating mother
Sites / Locations
- Bangabandhu Sheikh Mujib Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atorvastatin and zinc
Atorvastatin and placebo
Arm Description
46 Hyperlipidemic patients are included in this arm who will receive Atorvastatin and Zinc. Zinc tablets of 30mg will be used once daily according to randomization along with Atorvastatin.
46 Hyperlipidemic patients are included in this arm who will receive Atorvastatin and placebo. Placebo tablets of 30mg will be used once daily according to randomization along with Atorvastatin.
Outcomes
Primary Outcome Measures
Change of TC
Secondary Outcome Measures
Change of LDL-C
Change of HDL-C
Change of TG
Full Information
NCT ID
NCT05395143
First Posted
May 24, 2022
Last Updated
May 24, 2022
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT05395143
Brief Title
Study to Assess the Effect of Zinc in Atorvastatin Treated Hyperlipidemic Patients
Official Title
Study to Assess the Effect of Zinc in Atorvastatin Treated Hyperlipidemic Patients: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 10, 2022 (Anticipated)
Study Completion Date
July 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was 8 weeks randomized, double-blind, placebo-controlled trial to assess the effect of zinc in Atorvastatin treated hyperlipidemic 92 patients. Participants were assessed at baseline, and 8 weeks. Subjects were randomized to receive either atorvastatin+placebo in one arm or atorvastatin +zinc 30mg tablet in another arm daily for 8 weeks. The outcome was the measure of fasting lipid profile, sgpt, serum creatinine at baseline and after 8 weeks following the intervention.
Detailed Description
Hyperlipidemia is a pathological disorder that includes raised concentration of serum cholesterol, LDL and triglycerides (TGs). It is one of the most important triggering factors for the development of cardiovascular disease. As a consequence, this disorder ultimately increases the mortality rate since cardiovascular disease (CVD) is globally the most common cause of death. Various studies have demonstrated that the prevalence rate of CVD in Bangladesh is 0.33% to 19.6% (Malik, A., 1976 and Zaman, M.M. et al, 2007) and hyperlipidaemia is 46%. Triglycerides, cholesterol, and lipoproteins are associated with the pathogenesis of coronary artery disease, especially atherosclerosis. Atherosclerotic lesions may be the consequence of reduced serum high-density lipoprotein (HDL) and increased triglycerides level. Triglyceride concentrations of about 1.7 mmol/L would be considered by many to be the point beyond which risk for coronary artery disease begins. Triglyceride concentrations are commonly increased in diabetes mellitus, particularly the insulin-resistant type, noninsulin-dependent diabetes mellitus (NIDDM), and indicate an enhanced risk of coronary artery disease. Hypercholesterolemia also enhances microvascular dysfunction by stimulating nitro-oxidative stress and induction of inflammation. This mechanism leads to the development of myocardial infarction. Normalization of serum lipid profile is the logical step to prevent atherosclerotic events such as myocardial infarction, ischaemic stroke, peripheral vascular disease and this will reduce the mortality rate. As hyperlipidemia is a flexible condition, it can be modified by alteration of dietary habit, lifestyle change, and applications of various medications which interfere with lipid metabolism with the body. In that case, statin medication is the most suitable therapy for hyperlipidemia. The 2014 ACC (American College of Cardiology) / AHA (American Heart Association) guidelines have highlighted the benefits of statin therapy. But despite the statins being very effective drug recommended target lipid lowering levels are not always achieved. Moreover, long-term high-dose statin therapy may give rise to some adverse effects. On the other hand, many other lipid lowering agents are available in the market but they are not able to achieve the target lipid lowering effect always and long term use of these drugs may promote some adverse effects. They are also costly. Therefore, exploration of alternative, affordable, efficacious with less adverse effects drugs should be the next point of interest for further study. Besides, the repeated incidence of cardiovascular disease brings lingering hazards for the health. This situation develops the requirement for an add-on lipid-lowering agent along with conventional statin therapy. In that case, Zinc could be an agent added along with conventional statin therapy to normalize the lipid profile. Zinc is an important micronutrient of the human body which is implicated as a component in various systemic wellbeing. Several studies found that zinc might have protective effect in the prevention of atherosclerosis. Effect of Zinc on lipid profile by some studies revealed that it can lower serum total cholesterol, LDL cholesterol, triglycerides and increase the HDL levels. Therefore, the current study will explore the combination of lipid-lowering activity of atorvastatin and zinc. This study will be a randomized, double blind, placebo controlled trial. It will be conducted in the department of pharmacology, BSMMU in collaboration with the department of cardiology, BSMMU.A total of 92 patients suffering from hyperlipidemia will be selected according to inclusion and exclusion criteria. The diagnosis of patients and the selection of drug and dosage would be performed by a senior professor of the cardiology department. After completing the necessary formalities including informed consent of the patients, they will be enrolled and randomly allocated into two arms: control arm and intervention arm. Patient in intervention arm would consist of 46 patients who will receive Atorvastatin plus Zinc (30 mg) tablet once daily orally for 8 weeks. On the other hand, control arm would consist of 46 patients who will receive Atorvastatin plus placebo for 8 weeks. The lipid profile will be measured at baseline and 8 weeks follow up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Atorvastatin, Zinc, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, placebo-controlled trial where one group consists of 46 hyperlipidemic patients under treatment with atorvastatin and zinc; and another group consists of 46 hyperlipidemic patients under treatment with atorvastatin and placebo
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin and zinc
Arm Type
Experimental
Arm Description
46 Hyperlipidemic patients are included in this arm who will receive Atorvastatin and Zinc. Zinc tablets of 30mg will be used once daily according to randomization along with Atorvastatin.
Arm Title
Atorvastatin and placebo
Arm Type
Placebo Comparator
Arm Description
46 Hyperlipidemic patients are included in this arm who will receive Atorvastatin and placebo. Placebo tablets of 30mg will be used once daily according to randomization along with Atorvastatin.
Intervention Type
Drug
Intervention Name(s)
Zinc sulfate
Intervention Description
Zinc sulfate tablet 30mg once daily orally for 8 weeks along with Atorvastatin.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet 30mg once daily orally for 8 weeks along with Atorvastatin.
Primary Outcome Measure Information:
Title
Change of TC
Time Frame
from the baseline after 8-week treatment;
Secondary Outcome Measure Information:
Title
Change of LDL-C
Time Frame
from the baseline after 8-week treatment
Title
Change of HDL-C
Time Frame
from the baseline after 8-week treatment
Title
Change of TG
Time Frame
from the baseline after 8-week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 to 75 years
Sex: both male and female
Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension.
A person can develop hyperlipidemia if they have one or a combination of the following: Diagnostic criteria for dyslipidemic patients (NCEP ATP III guideline) Total Cholesterol > 240 mg/dl LDL-C > 100 mg/dl Triglyceride > 150 mg/dl HDL-C < 40 mg/dl
Exclusion Criteria:
Patients with renal impairment.
Patient with history of active liver disease (e.g. jaundice, hepatitis, cirrhosis)
Patients having hypersensitivity to drugs.
Patients with any systemic diseases or having serious infections or terminal illness (e.g.-tuberculosis, HIV, malignant tumor)
Pregnant woman
lactating mother
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rumana Sharmin, MD
Phone
01956834094
Email
fairysharmin03@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prof.Md. Sayedur Rahman, FCPS.M Phil
Phone
+8801971840757
Email
srkhasru@bsmmu.edu.bd
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Registrar
Phone
+889661064
Email
registrar@bsmmu.edu.bd
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Effect of Zinc in Atorvastatin Treated Hyperlipidemic Patients
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