RecruitingACTRN12612000640808

Decrease in blood lead levels by vitamin c among school going adolescents of Karachi- a cluster randomized control trial

lead detoxifying effects of ascorbic acid among school going adolescents age 13-18 years


Sponsor

Pakistan Science Foundation

Enrollment

150 participants

Start Date

May 5, 2012

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 13 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at whether taking Vitamin C (also known as ascorbic acid) can lower the amount of lead in the blood of teenagers. Lead is a toxic metal that can harm children's health, especially in areas near industrial zones. The study is being conducted in Karachi, Pakistan, and will give students Vitamin C supplements for 4 weeks to see if blood lead levels go down. You may be eligible if: - You are 13 to 18 years old - You are a student at a registered high school in the selected areas - You have lived in the selected area for at least 1 year - Your parents or guardians have given consent for you to participate - You also agree to participate yourself You may NOT be eligible if: - You have a chronic illness such as diabetes, high blood pressure, or epilepsy - You have kidney problems or are on dialysis - You have a bleeding disorder - You plan to move away within 2 months - You currently take any multivitamin supplements Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 func

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.


Locations(1)

Sindh, Pakistan

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ACTRN12612000640808