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NCT01261338 · ClinicalTrials.gov registry record · Early Phase 1
Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama
A Early Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
NCT01261338: Completed Early Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01261338 is a Early Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 28 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261338, a Early Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Because of industrial pollution, a large number of people in Anniston, Alabama, have elevated body burdens of the class of compounds known as polychlorinated biphenyls (PCBs). There is evidence that these compounds are associated with risks to health including diabetes. There is also evidence that the consumption of a non-absorbable dietary fat can reduce the level of compounds like PCBs. This clinical trial will test the hypothesis that a non-absorbable dietary fat can reduce the levels of PCBs in subjects in Anniston.
Primary Outcome
The outcome is the percent change in body burden of total PCB's measured over one year. Initially the percent of baseline is calculated as (value at one year / value at baseline) \*100, then this is examined modeling over time as compared to the 100% at baseline.
Interventions
- DRUG olestra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-10 |
| Phase | Early Phase 1 |
What the finished NCT01261338 record still lists
NCT01261338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which olestra is the first listed.
NCT01261338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01261338 about?
NCT01261338 is a clinical study titled "Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama". Because of industrial pollution, a large number of people in Anniston, Alabama, have elevated body burdens of the class of compounds known as polychlorinated biphenyls (PCBs). There is evidence that these compounds are associated with risks to health including diabetes. There is also evidence that t...
What is the current status of trial NCT01261338?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2010-12. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01261338?
The interventions under investigation include: olestra (DRUG).
Who is sponsoring clinical trial NCT01261338?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01261338's enrollment target sits among peer trials
28 938th of 2000 higher than 1,039 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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