NCT02745873

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

April 18, 2016

Last Update Submit

April 23, 2016

Conditions

Elevated Blood Lead Levels

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Arm A

EXPERIMENTAL

Ascorbic Acid 250 mg in tablet form was used.

Drug: Ascorbic Acid

Arm B

EXPERIMENTAL

Ascorbic Acid 500 mg in tablet form was used.

Drug: Ascorbic Acid

Interventions

Ascorbic AcidDRUG

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

Also known as: Vitamin C
Arm AArm B

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • school going adolescents, aged 13-18 years.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 20, 2016

Study Start

May 1, 2012

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

April 26, 2016

Record last verified: 2016-04