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

April 23, 2016 updated by: Muhammad Ilyas, Aga Khan University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Ascorbic Acid 250 mg in tablet form was used.
Drug: Ascorbic Acid
Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.
Other Names:
  • Vitamin C
Experimental: Arm B
Ascorbic Acid 500 mg in tablet form was used.
Drug: Ascorbic Acid
Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.
Other Names:
  • Vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Lead Level
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

Pakistan Science Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 23, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDVC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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