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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02745873
Acronym
LDVC
Enrollment
144
Registered
2016-04-20
Start date
2012-05-31
Completion date
2012-08-31
Last updated
2016-04-26

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

Conditions

Elevated Blood Lead Levels

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.

Interventions

DRUGAscorbic Acid

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

Sponsors

Pakistan Science Foundation
CollaboratorOTHER
Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Lead Level4 weeksMean 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026