Elevated Blood Lead LevelsPhase 2/3LDVCNCT02745873
Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial
A Phase 2/3 study testing Ascorbic Acid in people with Elevated Blood Lead Levels, run by Aga Khan University.
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… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Lead Levels
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1-school going adolescents, aged 13-18 years.
Who cannot join
- 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
About this study
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.
- Conditions
- Elevated Blood Lead Levels
- Being tested
- Ascorbic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C
Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Ascorbic Acid 250 mg in tablet form was used. Receives: Drug: Ascorbic Acid |
| Arm B | Experimental | Ascorbic Acid 500 mg in tablet form was used. Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood Lead LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Science Foundation
- Responsible party
- Principal investigator, Muhammad Ilyas, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745873
- Sponsor's protocol ID
- LDVC
- Acronym
- LDVC
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02745873
- Acronym / sponsor ID
- LDVC / LDVC
- Conditions
- Elevated Blood Lead Levels
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Pakistan Science Foundation
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Ascorbic AcidAscorbic Acid 250 mg in tablet form was used. |
| Arm B | Experimental | Drug: Ascorbic AcidAscorbic Acid 500 mg in tablet form was used. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1-school going adolescents, aged 13-18 years.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin CAscorbic Acid (vitamin-c) 500 mg in tablet form was used. | Drug | Arm A, Arm B |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
Related trials for Elevated Blood Lead Levels
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Reducing Lead Dust Exposure in Older Housing
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Not yet recruiting
Lead Exposure Intervention Program
Lead Exposure, High Blood Lead Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ascorbic Acid in people with Elevated Blood Lead Levels, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Lead Level (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.