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

Elevated Blood Lead Levels Clinical Trial

— LDVC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745873
• Other study ID #: LDVC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 18, 2016
• Last updated: April 23, 2016
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: April 2016
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan Science Foundation: Pakistan
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elevated Blood Lead Levels

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	Pakistan Science Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Lead Level	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	No