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Completed

NCT Number: NCT02745873

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

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.

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Key information

Conditions

Elevated Blood Lead Levels

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ascorbic acid

Drug

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

Other names: Vitamin C

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Pakistan Science Foundation

Registry information

Acronym: LDVC

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2016
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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