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Trial registered on ANZCTR


Registration number
ACTRN12622000549729
Ethics application status
Approved
Date submitted
18/02/2022
Date registered
8/04/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
8/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of administration of zinc supplementation on lipid profile and uric acid in smokers and non-smokers
Scientific title
Effect of administration of zinc supplementation on lipid profile and uric acid in smokers and non-smokers
Secondary ID [1] 306018 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
zinc deficiency 324652 0
hyperlipidemia 324653 0
hyperurecemia 325682 0
Condition category
Condition code
Cardiovascular 322104 322104 0 0
Other cardiovascular diseases
Mental Health 322105 322105 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will sub-divided into two groups that is smokers group and non-smokers group. The smokers group include 25 smoker volunteers and non-smokers group include 25 non-smoker volunteers .These groups take Zinc Gluconate 50mg once daily for 8 weeks by oral route. Adherence to the intervention check by weekly follow-up and drug tablet pack return strategy
Intervention code [1] 322420 0
Treatment: Drugs
Comparator / control treatment
Control group consist of 25 healthy volunteers . This group will not under treatment of zinc gluconate, but the group was on their routine daily food and liquids intake throughout the study session. Adherence to the check by weekly follow-up and by questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 329866 0
lipid profile test include low density lipo-protein(LDL), high density lipo-protein(HDL), total cholestrol (TC), triglycerides (TG) (unit=mg/dl)

To be assessed through an independent laboratory. Blood sample will be collected by a person not involved in study, in a vacutainer containing Clotting-Activator gel. Necessary measures will be taken to control conditions to preserve sample.
Timepoint [1] 329866 0
First at time of recruitment
After 8 weeks from start of intervention
Primary outcome [2] 329867 0
serum uric acid level

To be assessed through an independent laboratory. Blood sample will be collected by a person not involved in study, Necessary measures will be taken to control conditions to preserve sample.
Timepoint [2] 329867 0
First at the time of recruitment at zero day, then After 60 days (8 weeks) from the start of the intervention,
Secondary outcome [1] 404100 0
migraine attack severity checked by self structured questionnaire
Timepoint [1] 404100 0
First at time of recruitment through pre-questionnaire
After 8 weeks from start of intervention through post-questionnaire
Secondary outcome [2] 410054 0
serum zinc test.
Timepoint [2] 410054 0
First at time of recruitment at zero day then After 60 days/ 8 weeks from start of intervention

Eligibility
Key inclusion criteria
1)Volunteers age range between 18 to 60 years
2)Only healthy volunteers were included in control group
3)Smoker must use 5 cigarettes per day from last 2 years
4)Participants must not receiving prescribed medication like as lipid lowering agents (fibrins, statins) and uric acid lowering agents (allopurinol) which might interfere with study protocol.
5)Participants included in experimental group were not having the history of some chronic cardiovascular disease, respiratory disease, diabetes mellitus, hepatic or renal disorder or any other severe disease.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1)Female volunteers if pregnant, lactating or using contraceptive were excluded from the study.
2)Smokers under nicotine dependence treatment from last three months were excluded from the study.
3)Persons with decrease lipid profile, uric acid levels and normal level of plasma zinc were not participating in study.
4)Participants who were recently consuming supplements in the past three months were excluded from study
5)Persons with alcohol consumption history were not participated in study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
one group Intervention group consist of smokers and non-smokers groups given 50mg of zinc gluconate tablets once daily for 8 weeks
other group control group consist of healthy non-smokers,not given zinc gluconate just on their under routine daily food intake and liquids intake during study session.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Around 75 subjects will be recruited as per inclusion and exclusion criteria. Baseline data of clinical and laboratory values shall be assessed and recorded.
Subjects recruited will in two main groups; Control group includes 25 healthy non-smokers volunteers and intervention group consist of two sub-groups. Group A (smokers group) include 25 volunteers and will be given zinc gluconate 50mg once daily for 8 weeks while Group B (non-smokers group) include 25 volunteers and will receive the will be given zinc gluconate 50mg once daily for 8 weeks.
The subjects of each group shall be assessed for final data collection of laboratory and clinical values after 8 weeks of the intervention. Before taking final data, the subjects shall be assessed for adherence of treatment or intervention through self-made medication adherence questionnaire. The subject scoring more than 70% percent adherence shall be considered admissible for the final data acquisition and analysis. The data acquired shall be subjected to statistical testing for possible difference and significant observations.
The data of recruited patients shall be assessed and be presented in frequencies and percentages for the socio-demographic data.
After the data collection of post-intervention, the statistics tools t-test will be used for the assessment of differences in primary and secondary outcomes. For the comparison of lipid profile and uric acid levels in smokers and non-smokers group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2022
Actual
2/06/2022
Date of last participant enrolment
Anticipated
Actual
15/06/2022
Date of last data collection
Anticipated
Actual
16/08/2022
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 24395 0
Pakistan
State/province [1] 24395 0
Faisalabad/punjab

Funding & Sponsors
Funding source category [1] 310360 0
Self funded/Unfunded
Name [1] 310360 0
Amna Anwaar
Country [1] 310360 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Malik Hassan Mehmood
Address
Faculty of Pharmaceutical sciences, Government College University, Allama Iqbal Road Faisalabad Postal Code # 38000 Punjab, Pakistan
Country
Pakistan
Secondary sponsor category [1] 311497 0
None
Name [1] 311497 0
no
Address [1] 311497 0
nil
Country [1] 311497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310016 0
Institutional ethics review committee , government college university Faisalabad
Ethics committee address [1] 310016 0
Faculty of Pharmaceutical sciences, Government College University, Allama Iqbal Road Faisalabad Postal Code # 38000 Punjab, Pakistan
Ethics committee country [1] 310016 0
Pakistan
Date submitted for ethics approval [1] 310016 0
15/02/2022
Approval date [1] 310016 0
14/03/2022
Ethics approval number [1] 310016 0
Ref.No.GCUF/ERC/62

Summary
Brief summary
The purpose of this study is
1)To observe the effects of zinc supplements on lipid profile
2)To estimate the role of zinc in adjusting lipid profile and uric acid level in smokers and non-smokers
3)To evaluate the effect of zinc on cognition in smokers and non-smokers
it is the open labelled non-randomized trial in which two groups of 60 participants will included one control group will be include 10 healthy non-smoker volunteers and other group interventional group consist of n= 50 participants which will divided into two sub-groups smokers group and non-smokers group and the other group non-smokers group. each sub-group consist of n=25 participants
control group on their daily food and liquid intake with excercise with no zinc supplement treatment while in interventional group
both sub-groups will taken 50mg of zinc gluconate once daily for 8 weeks. the primary outcomes like as lipid profile(TC,TG, LDL, HDL) and serum uric acid and secondary outcome questionnaire will be analyzed at zero day or as pre-test values and after 8 weeks again taken primary outcomes as post-test values.
after that the data will be analyzed by SPSS for difference and comparative analysis through t-test
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116190 0
Dr Amna Anwaar
Address 116190 0
Faculty of Pharmaceutical sciences, Government College University, Allama Iqbal Road Faisalabad Postal Code # 38000 Punjab, Pakistan
Country 116190 0
Pakistan
Phone 116190 0
+92412551354
Fax 116190 0
Email 116190 0
[email protected]
Contact person for public queries
Name 116191 0
Amna Anwaar
Address 116191 0
Faculty of Pharmaceutical sciences, Government College University, Allama Iqbal Road Faisalabad Postal Code # 38000 Punjab, Pakistan
Country 116191 0
Pakistan
Phone 116191 0
+92412551354
Fax 116191 0
Email 116191 0
[email protected]
Contact person for scientific queries
Name 116192 0
Amna Anwaar
Address 116192 0
Faculty of Pharmaceutical sciences, Government College University, Allama Iqbal Road Faisalabad Postal Code # 38000 Punjab, Pakistan
Country 116192 0
Pakistan
Phone 116192 0
+92412551354
Fax 116192 0
Email 116192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data of all individuals, after necessary de-identification, shall be available for sharing that shall include demography, initial and final data of the study.
When will data be available (start and end dates)?
Immediately after publication of data and no end date
Available to whom?
The data shall be available to all researchers.
Available for what types of analyses?
Data can be available for meta-analysis and other study if proposed.
How or where can data be obtained?
Data can be obtained by sending request via email(email ID: [email protected]) to Principal Investigator who may after checking the proposal or reason, shall share the data in reply to that email.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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