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

Aga Khan University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Elevated Blood Lead Levels

Treatments: Drug: Ascorbic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02745873

LDVC

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Arm A

Experimental group

Description:

Ascorbic Acid 250 mg in tablet form was used.

Treatment:

Drug: Ascorbic Acid

Arm B

Experimental group

Description:

Ascorbic Acid 500 mg in tablet form was used.

Treatment:

Drug: Ascorbic Acid