Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000640808
Ethics application status
Approved
Date submitted
13/06/2012
Date registered
15/06/2012
Date last updated
28/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Decrease in blood lead levels by vitamin c among school going adolescents of Karachi- a cluster randomized control trial
Scientific title
lead detoxifying effects of ascorbic acid among school going adolescents age 13-18 years
Secondary ID [1] 280674 0
nil
Universal Trial Number (UTN)
U1111-1131-7862
Trial acronym
LDVC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Lead levels 286683 0
Vitamin C intake 286684 0
Condition category
Condition code
Blood 286998 286998 0 0
Other blood disorders
Diet and Nutrition 287000 287000 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ascorbic acid (vitamin C) is an essential water soluble vitamin that is a potent antioxidant as well as metabolic cofactor and plays an important role in many biological processes and biochemical functions (hydroxylation reactions).
Vitamin C (Ascorbic Acid ) will be given in two groups i.e 250 mg and 500 mg per oral in tablet form daily for 30 days.
Intervention code [1] 285074 0
Prevention
Comparator / control treatment
the study has dose comparision.
Control group
Dose comparison

Outcomes
Primary outcome [1] 287325 0
The Primary outcome is the mean decrease in blood lead levels.

This will be assessed by measuring the lead in blood by blood lead test at baseline and then 30 days after the intervention.
Timepoint [1] 287325 0
The Blood lead levels are measured at baseline and then after 30 days of intervention (Vitamin C) . (follow up of 30 days)
Secondary outcome [1] 297921 0
nil
Timepoint [1] 297921 0
nil

Eligibility
Key inclusion criteria
Inclusion criteria for cluster
High schools registered with Board of Secondary Education Karachi
1- Should have High school classes in the school.
2-Should have at least 15 students in these classes.
3-School authorities give permission for research project.

Inclusion Criteria (individuals)
1-Male/ female students studying in high school classes.
2-Resident of selected areas for at least one year.
3-Those whose parents / guardians consent
4-The adolescents selected also sign Assent form.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Crtieria:

1-Have History or presence of chronic illness or congenital disabilities. e.g Chronic Diarrhea, malabsorption, epilipsy, Diabetes, Hypertension.
2-Having diseases requiring red blood cell transfusion.
3-Known kidney problems or subjects on dialysis.
4-Those who have any known bleeding disorders.
5-Those who plan to leave their place of study in next two months (from start of study.
6-Those who use any type of multivitamins.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1-After the school authority’s permission, we will approach the high school classes and brief them about the research purpose, process and procedures. Those who will be willing to participate will be given a consent form and an assent form to discuss it with their parents. They will be also advised to request their parents to visit the school on the date provided by the students and the school authorities as per their feasibility to sign the consent form. In case they have any concern, they can contact us on phone for further clarification. Those adolescents whose parents will sign the consent and he/ she is also agree to participate in the study will be selected for inclusion in the study.
2-They will be then screened on the eligibility form for the conditions mentioned in the exclusion criteria.
3-On average at least 15 participants will be selected from each school. We will the fill a questionnaire for assessing their lead exposure and collect a blood sample.
4-Once the recruitment is completed from the school, It will be then randomized accordingly using Acluster software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1-A cluster randomization technique will used to allocate the treatment.
2-When recruitment is completed from two schools, They will be randomized using the Acluster (“Design and analysis of cluster randomization trails version 2.0 by World Health Organization, 2000”).
3-Every school has a cluster number, which will be entered in the software with cluster numbers and the intervention options will be also entered in the software.
4-A third person who is not related to the study will be asked to press the compute key to avoid any bias in the treatment allocation. Thus it will reveal the sequence of the treatment allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 4360 0
Pakistan
State/province [1] 4360 0
Sindh

Funding & Sponsors
Funding source category [1] 285434 0
University
Name [1] 285434 0
The Aga Khan University Karachi, Pakistan
Country [1] 285434 0
Pakistan
Funding source category [2] 285435 0
Government body
Name [2] 285435 0
Pakistan Science Foundation
Country [2] 285435 0
Pakistan
Primary sponsor type
Government body
Name
Pakistan Science Foundation
Address
Pakistan Science Foundation, 1-Constitution Avenue, Sector G-5/2, Islamabad (Pakistan).
Country
Pakistan
Secondary sponsor category [1] 284286 0
University
Name [1] 284286 0
The Aga Khan University Karachi, Pakistan
Address [1] 284286 0
Department of Community Health Science, The Aga Khan University, Stadium Road P.O: Box 3500,Postal Code: 74800, Karachi, Pakistan
Country [1] 284286 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287443 0
Ethical Review Committee , The Aga Khan University, Karachi, Pakistan
Ethics committee address [1] 287443 0
Ethical Review Committee, The Aga Khan University, Stadium Road P.O box: 3500, postal code 74800, Karachi. Pakistan
Ethics committee country [1] 287443 0
Pakistan
Date submitted for ethics approval [1] 287443 0
Approval date [1] 287443 0
06/02/2012
Ethics approval number [1] 287443 0
1981-CHS-ERC-11

Summary
Brief summary
In this study we want to assess the effects of Vitamin C (Ascorbic Acid) on decreasing the blood lead levels in adolescent’s age 13-18 years. A cluster Randomized control trial will be used to conduct the the study. We hypothesize that there will be at least two units (mg/dl) difference between the two intervention groups.
The purpose of this study is to investigate the role of ascorbic acid in minimizing the lead toxicity by decreasing the blood lead levels and to provide an economical and convenient and safe method of ameliorating the adverse effects of lead in developing countries.
Thus a minimum 3 cluster per group will be enough to detect this difference with 90 % power. We will give vitamin C in two groups. Each school (cluster) will be given one treatment only. These school are selected from different areas (Industrial/ commercial and residential). We will collect a blood sample and fill a questionnaire to assess the lead exposure at base line. They will be then given Vitamin C for 4 weeks. After 4 weeks we will collect the second blood sample to assess the decrease in blood levels. We will also assess their dietary vitamin C intake at the time of second blood sample through a food frequency questionnaire (FFQ).
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34306 0
Address 34306 0
Country 34306 0
Phone 34306 0
Fax 34306 0
Email 34306 0
Contact person for public queries
Name 17553 0
Muhammad Ilyas
Address 17553 0
Department of Community health Sciences
The Aga Khan University, Stadium Road
PO Box 3500, Postal code 74800, Karachi
Pakistan
Country 17553 0
Pakistan
Phone 17553 0
+92-345-2491680
Fax 17553 0
--
Email 17553 0
[email protected]
Contact person for scientific queries
Name 8481 0
Dr. Anwar-ul-Hassan Gilani, PhD, SI
Address 8481 0
Distinguished National Professor
Vice Chair, Research and Graduate studies
Department of Biological and Biomedical Sciences
The Aga Khan University, Stadium Road
PO Box 3500, Postal code 74800, Karachi
Pakistan
Country 8481 0
Pakistan
Phone 8481 0
+92-21-3486-4571
Fax 8481 0
+92-21-3493-4294
Email 8481 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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