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

NCT ID: NCT02745873

Last Updated: 2016-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Elevated Blood Lead Levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm A

Ascorbic Acid 250 mg in tablet form was used.

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.

Arm B

Ascorbic Acid 500 mg in tablet form was used.

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.

Interventions

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Ascorbic Acid

Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.

Intervention Type DRUG

Other Intervention Names

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Vitamin C

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pakistan Science Foundation

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Ilyas

Mr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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LDVC

Identifier Type: -

Identifier Source: org_study_id

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