Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial

Phase 2

Completed

• Conditions: Elevated Blood Lead Levels
• Interventions: Drug: Ascorbic Acid

• Registration Number: NCT02745873
• Lead Sponsor: Aga Khan University

Brief Summary

The toxic nature of lead has been recognized ubiquitous for than 2,000 years and today it is a persistent and common environmental contaminant in most parts of the world. Vitamin C is a strong antioxidant and a metabolic co factor playing an important role in many biological processes and biochemical functions (hydroxylation reactions). The research objective is to assess the effect of oral ascorbic acid supplementation 500mg and 250 mg once a day for 4 weeks on Blood Lead level among school going urban adolescents, using a cluster randomized trial study design. Ascorbic Acid (vitamin C) 250 and 500 mg will be administered in two study arms.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Last Update Submitted: 2016-04-23
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1-school going adolescents, aged 13-18 years.

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Exclusion Criteria

1. Children with history or presence of chronic illness or bleeding disorders, requiring red blood cell transfusion, dialysis
2. Using multivitamins
3. Those who planning to leave study place within 2 months of start of study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Ascorbic Acid	Ascorbic Acid 250 mg in tablet form was used.
Arm B	Ascorbic Acid	Ascorbic Acid 500 mg in tablet form was used.

Primary Outcome Measures

Name	Time	Method
Blood Lead Level	4 weeks	Mean Change in blood lead level is the main outcome of the study. It will be recorded as continuous variable and unit of measurement will be μg/dl.; Blood lead levels will be assessed at baseline before the start of intervention and at the end of the 4 weeks of intervention period in both arms.; Mean change will be calculated by taking difference between two the points as follow up (4 weeks) Blood lead levels minus baseline Blood Lead level.