Study to Assess the Effect of Zinc in Atorvastatin Treated Hyperlipidemic Patients

NCT05395143 | Unknown Phase 2

• 1 other identifier: BSMMU/2021/4030
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias

Keywords

Atorvastatin; Zinc; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Change of TC

  from the baseline after 8-week treatment;

Secondary Outcomes (3)

• Change of LDL-C

  from the baseline after 8-week treatment

• Change of HDL-C

  from the baseline after 8-week treatment

• Change of TG

  from the baseline after 8-week treatment

Study Arms (2)

Atorvastatin and zinc

EXPERIMENTAL

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.

Drug: Zinc sulfate

Atorvastatin and placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Zinc sulfate DRUG

Zinc sulfate tablet 30mg once daily orally for 8 weeks along with Atorvastatin.

Atorvastatin and zinc

Placebo DRUG

Placebo tablet 30mg once daily orally for 8 weeks along with Atorvastatin.

Atorvastatin and placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Central Study Contacts

Rumana Sharmin, MD

CONTACT

01956834094; fairysharmin03@gmail.com

Prof.Md. Sayedur Rahman, FCPS.M Phil

CONTACT

+8801971840757; srkhasru@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: May 1, 2021
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

BA (1)