Early Phase 1
N=28
Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama
Toxic Effect of Other Corrosive Organic Compounds
Bottom Line
View on ClinicalTrials.gov: NCT01261338 ↗Enrolled (actual)
28
Serious AEs
14.3%
Results posted
Sep 2020
Primary outcome: Primary: Percent Change From Baseline for Total PCB Levels — 92; 96 % of baseline total PCBs
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- olestra (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline for Total PCB Levels |
92; 96 | — |
| PRIMARY Rate of Change of Lipid Adjusted PCB Levels |
-0.0829; -0.0413 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Elevated blood level of PCBs
Exclusion Criteria
- Pregnancy
- Breast-feeding
- Weight-loss medication
- Gastrointestinal disease
Data sourced from ClinicalTrials.gov (NCT01261338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.