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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000640808

Acronym

LDVC

Enrollment

150

Registered

2012-06-15

Start date

2012-05-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

13 Years to 18 Years

Healthy volunteers

Yes

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.

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.

Outcome results